Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 53 of 292 for:    ASPIRIN AND clopidogrel AND dual

EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events (EDUCATE)

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: NCT01069003
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Drug: Placebo Arm
Drug: Thienopyridine Therapy
Device: Surveillance Arm
Enrollment 2272
Recruitment Details  
Pre-assignment Details Enrolled 2272 but only 2262 subjects were analysis receiving the Endeavor stent only.
Arm/Group Title Placebo Thienopyridine Therapy Surveillance Arm
Hide Arm/Group Description

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).

Placebo (12-Month Arm): Placebo

ASA: 75 mg - 325 mg Aspirin(ASA)

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).

Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg

ASA: 75 mg - 325 mg Aspirin(ASA)

Non randomized subjects followed for total of 24 months
Period Title: Overall Study
Started 399 412 1451
Completed 353 358 976
Not Completed 46 54 475
Arm/Group Title Placebo Arm Thienopyridine Therapy Surveillance Arm Total
Hide Arm/Group Description

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).

Placebo (12-Month Arm): Placebo

ASA: 75 mg - 325 mg Aspirin(ASA)

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).

Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg

ASA: 75 mg - 325 mg Aspirin(ASA)

Non randomized subjects followed for total of 24 months Total of all reporting groups
Overall Number of Baseline Participants 399 412 1451 2262
Hide Baseline Analysis Population Description
The intent to treat arm contains non randomized subjects followed through 24 months
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 399 participants 412 participants 1451 participants 2262 participants
62.8  (10.7) 62.5  (10.7) 64.6  (11.3) 63.3  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 399 participants 412 participants 1451 participants 2262 participants
Female
122
  30.6%
116
  28.2%
449
  30.9%
687
  30.4%
Male
277
  69.4%
296
  71.8%
1002
  69.1%
1575
  69.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 399 participants 412 participants 1451 participants 2262 participants
United States 372 385 1409 2166
Canada 27 27 42 96
1.Primary Outcome
Title Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects
Hide Description [Not Specified]
Time Frame Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Arm Thienopyridine Therapy Surveillance Arm
Hide Arm/Group Description:

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).

Placebo (12-Month Arm): Placebo

ASA: 75 mg - 325 mg Aspirin(ASA)

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).

Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg

ASA: 75 mg - 325 mg Aspirin(ASA)

Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
Overall Number of Participants Analyzed 392 393 1451
Measure Type: Number
Unit of Measure: Percentage of participants
4.3 4.8 16.9
2.Primary Outcome
Title Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects
Hide Description

All definite and probable Stent Thrombosis (ST) are adjudicated by an independent committee according to the definition based on Academic Research Consortium (ARC)

Definite is defined as angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region and at least 1 of the following: Acute ischemic symptoms, Ischemic ECG changes, Elevated cardiac biomarkers

Probable defined as any unexplained death within the first 30 days of procedure and any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

Time Frame Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Arm Thienopyridine Therapy Surveillance Arm
Hide Arm/Group Description:

Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).

Placebo (12-Month Arm): Placebo

ASA: 75 mg - 325 mg Aspirin(ASA)

Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).

Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg

ASA: 75 mg - 325 mg Aspirin(ASA)

Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
Overall Number of Participants Analyzed 392 393 1451
Measure Type: Number
Unit of Measure: percentage of participants
1.0 0.5 2.4
3.Primary Outcome
Title Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects
Hide Description [Not Specified]
Time Frame Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Arm Thienopyridine Therapy Surveillance Arm
Hide Arm/Group Description:

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).

Placebo (12-Month Arm): Placebo

ASA: 75 mg - 325 mg Aspirin(ASA)

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).

Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg

ASA: 75 mg - 325 mg Aspirin(ASA)

Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
Overall Number of Participants Analyzed 392 393 1451
Measure Type: Number
Unit of Measure: Percentage of participants
1.8 2.0 4.8
Time Frame All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Arm Thienopyridine Therapy Surveillance Arm
Hide Arm/Group Description

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).

Placebo (12-Month Arm): Placebo

ASA: 75 mg - 325 mg Aspirin(ASA)

Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).

Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg

ASA: 75 mg - 325 mg Aspirin(ASA)

Non randomized subjects followed through 24 months
All-Cause Mortality
Placebo Arm Thienopyridine Therapy Surveillance Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Arm Thienopyridine Therapy Surveillance Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   117/399 (29.32%)      111/412 (26.94%)      664/1451 (45.76%)    
Blood and lymphatic system disorders       
Anaemia  1  5/399 (1.25%)  6 2/412 (0.49%)  2 37/1451 (2.55%)  41
Cardiac disorders       
Acute Myocardial Infarction  1  7/399 (1.75%)  7 3/412 (0.73%)  3 55/1451 (3.79%)  59
Angina Pectoris  1  10/399 (2.51%)  10 3/412 (0.73%)  3 39/1451 (2.69%)  40
Angina Unstable  1  1/399 (0.25%)  1 0/412 (0.00%)  0 31/1451 (2.14%)  32
Atrial Fibrillation  1  6/399 (1.50%)  7 4/412 (0.97%)  4 24/1451 (1.65%)  26
Atrial Flutter  1  0/399 (0.00%)  0 1/412 (0.24%)  1 2/1451 (0.14%)  2
Bradycardia  1  1/399 (0.25%)  1 0/412 (0.00%)  0 14/1451 (0.96%)  14
Cardiac Failure Congestive  1  3/399 (0.75%)  7 3/412 (0.73%)  3 39/1451 (2.69%)  53
Cardiogenic Shock  1  0/399 (0.00%)  0 1/412 (0.24%)  1 3/1451 (0.21%)  4
Coronary Artery Disease  1  13/399 (3.26%)  13 18/412 (4.37%)  20 0/1451 (0.00%)  0
Coronary Artery Occlusion  1  0/399 (0.00%)  0 1/412 (0.24%)  1 0/1451 (0.00%)  0
Coronary Artery Stenosis  1  1/399 (0.25%)  1 2/412 (0.49%)  2 0/1451 (0.00%)  0
In-Stent Coronary Artery Restenosis  1  3/399 (0.75%)  3 6/412 (1.46%)  6 0/1451 (0.00%)  0
Myocardial Infarction  1  3/399 (0.75%)  3 0/412 (0.00%)  0 0/1451 (0.00%)  0
Ventricular Tachycardia  1  1/399 (0.25%)  1 1/412 (0.24%)  1 0/1451 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  1/399 (0.25%)  1 0/412 (0.00%)  0 1/1451 (0.07%)  1
Gastrointestinal disorders       
Abdominal Pain  1  3/399 (0.75%)  3 1/412 (0.24%)  1 15/1451 (1.03%)  21
Gastrointestinal Haemorrhage  1  5/399 (1.25%)  5 7/412 (1.70%)  7 44/1451 (3.03%)  51
Retroperitoneal Haemorrhage  1  1/399 (0.25%)  1 0/412 (0.00%)  0 1/1451 (0.07%)  1
General disorders       
Chest Discomfort  1  2/399 (0.50%)  2 2/412 (0.49%)  2 6/1451 (0.41%)  6
Chest Pain  1  11/399 (2.76%)  12 9/412 (2.18%)  10 97/1451 (6.69%)  128
Death  1  1/399 (0.25%)  1 0/412 (0.00%)  0 8/1451 (0.55%)  8
Hernia  1  0/399 (0.00%)  0 1/412 (0.24%)  1 12/1451 (0.83%)  12
Non-Cardiac Chest Pain  1  3/399 (0.75%)  3 5/412 (1.21%)  7 15/1451 (1.03%)  16
Pyrexia  1  0/399 (0.00%)  0 1/412 (0.24%)  1 3/1451 (0.21%)  3
Immune system disorders       
Hypersensitivity  1  1/399 (0.25%)  1 0/412 (0.00%)  0 1/1451 (0.07%)  1
Infections and infestations       
Diverticulitis  1  1/399 (0.25%)  1 2/412 (0.49%)  2 2/1451 (0.14%)  2
Infection  1  0/399 (0.00%)  0 3/412 (0.73%)  4 11/1451 (0.76%)  13
Pneumonia  1  5/399 (1.25%)  5 2/412 (0.49%)  2 20/1451 (1.38%)  26
Urinary Tract Infection  1  1/399 (0.25%)  1 1/412 (0.24%)  1 7/1451 (0.48%)  9
Injury, poisoning and procedural complications       
Thrombosis In Device  1  2/399 (0.50%)  2 2/412 (0.49%)  2 18/1451 (1.24%)  18
Investigations       
Cardiac Enzymes Increased  1  0/399 (0.00%)  0 1/412 (0.24%)  1 15/1451 (1.03%)  16
Metabolism and nutrition disorders       
Diabetes Mellitus  1  0/399 (0.00%)  0 1/412 (0.24%)  1 2/1451 (0.14%)  2
Diabetes Mellitus Inadequate Control  1  2/399 (0.50%)  2 0/412 (0.00%)  0 1/1451 (0.07%)  1
Hyperkalaemia  1  1/399 (0.25%)  1 0/412 (0.00%)  0 4/1451 (0.28%)  4
Hypokalaemia  1  1/399 (0.25%)  1 0/412 (0.00%)  0 5/1451 (0.34%)  5
Musculoskeletal and connective tissue disorders       
Back Pain  1  2/399 (0.50%)  2 2/412 (0.49%)  4 9/1451 (0.62%)  10
Pain In Extremity  1  1/399 (0.25%)  1 3/412 (0.73%)  3 0/1451 (0.00%)  0
Nervous system disorders       
Cerebrovascular Accident  1  4/399 (1.00%)  4 3/412 (0.73%)  3 19/1451 (1.31%)  22
Headache  1  2/399 (0.50%)  2 1/412 (0.24%)  1 0/1451 (0.00%)  0
Presyncope  1  1/399 (0.25%)  1 0/412 (0.00%)  0 1/1451 (0.07%)  1
Transient Ischaemic Attack  1  3/399 (0.75%)  3 3/412 (0.73%)  3 3/1451 (0.21%)  3
Renal and urinary disorders       
Haematuria  1  0/399 (0.00%)  0 2/412 (0.49%)  2 6/1451 (0.41%)  6
Renal Failure  1  0/399 (0.00%)  0 2/412 (0.49%)  2 14/1451 (0.96%)  16
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  3/399 (0.75%)  3 2/412 (0.49%)  2 20/1451 (1.38%)  33
Dyspnoea  1  2/399 (0.50%)  4 4/412 (0.97%)  4 19/1451 (1.31%)  19
Epistaxis  1  1/399 (0.25%)  1 1/412 (0.24%)  1 7/1451 (0.48%)  7
Pulmonary Oedema  1  0/399 (0.00%)  0 1/412 (0.24%)  1 7/1451 (0.48%)  9
Skin and subcutaneous tissue disorders       
Rash  1  1/399 (0.25%)  1 0/412 (0.00%)  0 4/1451 (0.28%)  4
Surgical and medical procedures       
Therapeutic Embolisation  1  0/399 (0.00%)  0 1/412 (0.24%)  1 2/1451 (0.14%)  2
Vascular disorders       
Haemorrhage  1  0/399 (0.00%)  0 2/412 (0.49%)  2 7/1451 (0.48%)  8
Hypotension  1  1/399 (0.25%)  1 1/412 (0.24%)  1 10/1451 (0.69%)  11
Peripheral Ischaemia  1  1/399 (0.25%)  1 0/412 (0.00%)  0 4/1451 (0.28%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Arm Thienopyridine Therapy Surveillance Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/399 (0.00%)      0/412 (0.00%)      90/1451 (6.20%)    
General disorders       
Chest Pain  1  0/399 (0.00%)  0 0/412 (0.00%)  0 90/1451 (6.20%)  96
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: Sidney Cohen, Sr. Clinical Medical Advisor
Organization: Medtronic
Phone: 707-591-7277
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01069003     History of Changes
Other Study ID Numbers: IP114
First Submitted: February 12, 2010
First Posted: February 17, 2010
Results First Submitted: June 29, 2015
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016