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Trial record 36 of 1302 for:    ASPIRIN AND Platelet Aggregation

Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)

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ClinicalTrials.gov Identifier: NCT00799396
Recruitment Status : Completed
First Posted : November 27, 2008
Results First Posted : March 28, 2016
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Alan Shuldiner, University of Maryland, College Park

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Platelet Aggregation Inhibitors
Coronary Heart Disease
Interventions Drug: Clopidogrel
Drug: Aspirin
Enrollment 682
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Overall Study
Hide Arm/Group Description

Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.

Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days

Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment

Period Title: Clopidogrel Treatment
Started 682
Completed 669
Not Completed 13
Reason Not Completed
Adverse Event             6
Physician Decision             5
Withdrawal by Subject             2
Period Title: Clopidogrel Plus Aspirin
Started 669
Completed 663
Not Completed 6
Reason Not Completed
Adverse Event             2
Physician Decision             4
Arm/Group Title Overall Study
Hide Arm/Group Description

Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.

Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days

Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment

Overall Number of Baseline Participants 682
Hide Baseline Analysis Population Description
Participants were recruited from the Old Order Amish of Lancaster, Pennsylvania. They are well suited for genetic studies because they are a homogenous, closed, founder population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 682 participants
45.5  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants
Female
343
  50.3%
Male
339
  49.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 682 participants
682
1.Primary Outcome
Title Changes in Platelet Function in Response to Clopidogrel
Hide Description Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.
Time Frame Measured at baseline, and after clopidogrel treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:

Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.

Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days

Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment

PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation

PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation

Overall Number of Participants Analyzed 669
Mean (Standard Deviation)
Unit of Measure: percentage of maximum aggregation change
PRP ADP 20 38.51  (14.30)
PRP Collagen 5 14.06  (15.01)
2.Primary Outcome
Title Changes in Platelet Function in Response to Clopidogrel Plus Aspirin
Hide Description Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation
Time Frame Measured at baseline, and after clopidogrel plus aspirin treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:

Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.

Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days

Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment

PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation

PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation

Overall Number of Participants Analyzed 663
Mean (Standard Deviation)
Unit of Measure: percentage of max aggregation change
PRP ADP 20 41.21  (13.09)
PRP Collagen 5 56.64  (14.44)
Time Frame 37 days
Adverse Event Reporting Description Adverse event data were collected during both intervention periods and for 30 days after the final study visit. There were 6 Adverse Events during the Clopidogrel Treatment Arm and 2 Adverse Events during the Clopidogrel plus Aspirin Arm. This does not exceed the threshold for reporting Other Adverse Events.
 
Arm/Group Title Overall Study
Hide Arm/Group Description

Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.

Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days

Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment

All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   0/682 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Study
Affected / at Risk (%)
Total   0/682 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alan R Shuldiner, MD
Organization: University of Maryland School of Medicine
Phone: 410-706-1623
EMail: ashuldin@medicine.umaryland.edu
Publications of Results:
Layout table for additonal information
Responsible Party: Alan Shuldiner, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT00799396     History of Changes
Other Study ID Numbers: HP-00043419
U01 HL074518-01
U01GM074518 ( U.S. NIH Grant/Contract )
First Submitted: November 26, 2008
First Posted: November 27, 2008
Results First Submitted: February 18, 2016
Results First Posted: March 28, 2016
Last Update Posted: August 22, 2019