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Trial record 31 of 292 for:    ASPIRIN AND clopidogrel AND dual

XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort (XVU-AV DAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01106534
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Collaborators:
Baim Institute for Clinical Research
Bristol-Myers Squibb
Eli Lilly and Company
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Total Occlusion of Coronary Artery
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Interventions Drug: placebo + aspirin
Drug: clopidogrel + aspirin OR prasugrel + aspirin
Device: XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
Enrollment 870
Recruitment Details Additional 3000 patients were enrolled in the second enrollment phase and had completed phase I at 1 year. In phase II, 870 patients from these were transferred to AV-DAPT cohort and followed from 1 year to 33 months, and the remaining who did not participate in AV-DAPT cohort will be followed for the first year only.
Pre-assignment Details

Outcome measures of participants of XIENCE V USA trial of phase I followed up until 1 year from index procedure are available in the study with ID NCT00676520.

Outcome measures of participants belonging to XIENCE V USA long-term follow-up cohort of phase II (followed up from year 1 to year 5) are available in the study with ID NCT01120379.

Arm/Group Title Second Enrollment Phase of XIENCE V® USA
Hide Arm/Group Description Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.
Period Title: Overall Study
Started 2997
Completed 2960
Not Completed 37
Reason Not Completed
Withdrawal by Subject             18
Lost to Follow-up             2
Death             16
Physician Decision             1
Arm/Group Title Second Enrollment Phase of XIENCE V® USA
Hide Arm/Group Description Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular.
Overall Number of Baseline Participants 2997
Hide Baseline Analysis Population Description
Baseline characteristics are provided for 2997 patients recruited in the second enrollment phase.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2997 participants
64.27  (10.39)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2997 participants
< 65 years 1587
>= 65 to < 75 years 922
>= 75 years 488
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2997 participants
Female
870
  29.0%
Male
2127
  71.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2997 participants
American Indian or Alaskan Native 23
Asian 49
Black or African Heritage 231
Native Hawaiian or Pacific Islander 7
White 2577
Hispanic or Latino 117
Other 15
[1]
Measure Description: Patient may be counted in more than one category
1.Primary Outcome
Title Incidence of Composite of All Death, MI and Stroke (Defined as MACE)
Hide Description [Not Specified]
Time Frame 12-33 months post-stent
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Arm/Group Title 12 Month DAPT Arm 30 Month DAPT Arm
Hide Arm/Group Description:

placebo + aspirin

placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

clopidogrel + aspirin OR prasugrel + aspirin

clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Incidence of ARC Definite or Probable ST
Hide Description [Not Specified]
Time Frame 12-33 months post-stent
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Arm/Group Title 12 Month DAPT Arm 30 Month DAPT Arm
Hide Arm/Group Description:

placebo + aspirin

placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

clopidogrel + aspirin OR prasugrel + aspirin

clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)
Hide Description [Not Specified]
Time Frame 12-33 months post-stent
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Arm/Group Title 12 Month DAPT Arm 30 Month DAPT Arm
Hide Arm/Group Description:

placebo + aspirin

placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

clopidogrel + aspirin OR prasugrel + aspirin

clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title MACE for ITT Population
Hide Description [Not Specified]
Time Frame 12 through 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Arm/Group Title 12 Month DAPT Arm 30 Month DAPT Arm
Hide Arm/Group Description:

placebo + aspirin

placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

clopidogrel + aspirin OR prasugrel + aspirin

clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title ST for ITT Population
Hide Description [Not Specified]
Time Frame 12 through 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Arm/Group Title 12 Month DAPT Arm 30 Month DAPT Arm
Hide Arm/Group Description:

placebo + aspirin

placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

clopidogrel + aspirin OR prasugrel + aspirin

clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Major Bleeding for ITT Population
Hide Description [Not Specified]
Time Frame 12 through 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Arm/Group Title 12 Month DAPT Arm 30 Month DAPT Arm
Hide Arm/Group Description:

placebo + aspirin

placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

clopidogrel + aspirin OR prasugrel + aspirin

clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title MACE for Treatment Population
Hide Description [Not Specified]
Time Frame 12 through 30 months and 12 through 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Arm/Group Title 12 Month DAPT Arm 30 Month DAPT Arm
Hide Arm/Group Description:

placebo + aspirin

placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

clopidogrel + aspirin OR prasugrel + aspirin

clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title ST for Treatment Population
Hide Description [Not Specified]
Time Frame 12 through 30 months and 12 through 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Arm/Group Title 12 Month DAPT Arm 30 Month DAPT Arm
Hide Arm/Group Description:

placebo + aspirin

placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

clopidogrel + aspirin OR prasugrel + aspirin

clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Major Bleeding for Treatment Population
Hide Description [Not Specified]
Time Frame 12 through 30 months and 12 through 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
Arm/Group Title 12 Month DAPT Arm 30 Month DAPT Arm
Hide Arm/Group Description:

placebo + aspirin

placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.

clopidogrel + aspirin OR prasugrel + aspirin

clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 5 years
Adverse Event Reporting Description Adverse events were not be reported here as the participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
 
Arm/Group Title Second Enrollment Phase of XIENCE V® USA
Hide Arm/Group Description The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
All-Cause Mortality
Second Enrollment Phase of XIENCE V® USA
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Second Enrollment Phase of XIENCE V® USA
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Second Enrollment Phase of XIENCE V® USA
Affected / at Risk (%)
Total   0/0 
The participants enrolled in this study will be followed by Abbott Vacular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the outcomes.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David R Rutledge
Organization: Abbott Vascular
Phone: (408) 845-3820
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01106534     History of Changes
Other Study ID Numbers: 06-374C
First Submitted: April 16, 2010
First Posted: April 20, 2010
Results First Submitted: July 31, 2015
Results First Posted: June 28, 2016
Last Update Posted: June 28, 2016