A Phase 4 interventional study of Clopidogrel and Aspirin in Platelet Aggregation Inhibitors and Coronary Heart Disease, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Treatment
One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or clopidogrel. However, studies have shown that not all people respond to these medications. The variance in treatment response may be linked to genetics. This study will examine the effects of aspirin and clopidogrel in a population whose genes are well known in order to determine the role that genes play in treatment responses.
CHD is the leading cause of death in the United States. Anti-platelet agents lessen platelet aggregation and are used commonly to prevent recurrent CHD events. Two of the most common anti-platelet agents are aspirin and clopidogrel. However, up to 25% to 30% of people do not respond to these medications. Evidence indicates that treatment response may be related to genetics. The purpose of this study is to determine specific gene variants that predict response to aspirin and clopidogrel therapy.
This study is part of a larger group of studies called the Pharmacogenomics Research Network (PGRN). Participants will include the Old Order Amish of Lancaster, Pennsylvania. They are well suited for genetic studies because they are a homogenous, closed, founder population. Participants will receive 300 mg of clopidogrel on the first day, then 75 mg of clopidogrel per day for the next 6 days. On the last day of clopidogrel treatment, participants will take a single dose of 324 mg aspirin. Participants will undergo platelet function tests before and after clopidogrel alone, and then again after taking clopidogrel plus aspirin. Using the gene variation profiles across the genome, researchers will analyze which genes correspond to treatment response.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 682 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.
Drug: Clopidogrel · Drug: Aspirin
300 mg on first day, then 75 mg per day for the next 6 days
Single dose of 324 mg on the last day of clopidogrel treatment
Changes in Platelet Function in Response to Clopidogrel
Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.
Time frame: Measured at baseline, and after clopidogrel treatment
Changes in Platelet Function in Response to Clopidogrel Plus Aspirin
Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation
Time frame: Measured at baseline, and after clopidogrel plus aspirin treatment
| Milestone | Overall Study |
|---|---|
| Started | 682 |
| Completed | 669 |
| Not completed | 13 |
| Withdrew: Adverse event | 6 |
| Withdrew: Physician decision | 5 |
| Withdrew: Withdrawal by subject | 2 |
| Milestone | Overall Study |
|---|---|
| Started | 669 |
| Completed | 663 |
| Not completed | 6 |
| Withdrew: Adverse event | 2 |
| Withdrew: Physician decision | 4 |
Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.
| percentage of maximum aggregation change | Overall Study |
|---|---|
| PRP ADP 20 | 38.51 ± 14.30 |
| PRP Collagen 5 | 14.06 ± 15.01 |
Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation
| percentage of max aggregation change | Overall Study |
|---|---|
| PRP ADP 20 | 41.21 ± 13.09 |
| PRP Collagen 5 | 56.64 ± 14.44 |
Collected over 37 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Study | — | 0/682 (0%) | 0/682 (0%) |
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(years) | Overall Study |
|---|---|
| Mean | 45.5 ± 13.5 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 343 |
| Male | 339 |
| Region of Enrollment(participants) | Overall Study |
|---|---|
| United States | 682 |
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore