A Genomic Approach for Clopidogrel in Caribbean Hispanics (NCT03419325) | Clinical Trial Compass
CompletedEarly Phase 1
A Genomic Approach for Clopidogrel in Caribbean Hispanics
Puerto Rico150 participantsStarted 2020-09-01
Plain-language summary
Clopidogrel is a prescription medicine used to minimize blood clot formation in patients with cardiovascular disease, particularly those undergoing heart catheterization and stroke. A substantial amount of medical evidence has proven that patients with stroke or heart diseases can benefit from this medicine. However, significant variability in such expected benefits has been found among individuals receiving clopidogrel, with some patients not having the benefit of reduced complications and adverse cardiovascular events. Prior studies have demonstrated a significant association between certain variants on patient's genes (e.g., CYP2C19) and poor response to clopidogrel and, therefore, major adverse cardiovascular events. Variation in other genes and other factors such as platelet activation, weight, diabetes mellitus (a medical condition that produces high blood sugar), concomitant use of other drugs, and smoking status have also been proposed to be related to the same adverse outcomes. In this study, the investigators would like to determine a possible association between these genes and the response to the medication among Caribbean Hispanic cardiovascular patients on clopidogrel. In other populations, it is known that patients with certain genetic variants have lower or magnified responses to this medication when compared to those individuals taking the same dose and not carrying the genetic variations. However, a fundamental gap remains in understanding whether the genomic diversity of Caribbean Hispanics accounts for the observed high inter-individual variability of clinical outcomes to preventive dual antiplatelet therapy (DAPT) with clopidogrel.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Caribbean Hispanics (Puerto Ricans, Dominicans or Cubans) residing in Puerto Rico, whose parents are also of Hispanic origin
* Both genders (Males/Females)
* Age ≥21
* Receiving Clopidogrel for therapeutic indications.
* No clinically active hepatic abnormality
* The ability to understand the requirements of the study
* The ability to comply with study procedures and protocol
* A female patient is eligible to enter the study if she is of child-bearing potential and not pregnant or nursing, or not of child-bearing potential
Exclusion Criteria:
* Non-Hispanic patients (race/ethnicity is self-reported by the patients)
* Currently enrolled in another active research protocols at the participating institutions
* BUN \>30
* Creatinine \>2.0 mg/dL
* Platelet count \<100,000/mm3
* Nasogastric or enteral feedings
* Acute illness (e.g., sepsis, infection, anemia)
* HIV/AIDS, Hepatitis B patients
* Alcoholism and drug abuse
* Patients with any cognitive and mental health impairment
* Sickle cell patients
* Active malignancy
* Patients taking another antiplatelet
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial specifically studied Caribbean Hispanics and how their genetics affect how well clopidogrel works — given my background, would my genetic makeup be similar enough to the people studied that the findings might be relevant to my situation?
2Since this was a Phase 1 trial focused on a genomic approach to clopidogrel use, what do the results tell us about whether genetic testing before prescribing clopidogrel could help reduce my personal risk of a major cardiovascular event or stroke?
3The trial is now completed and was measuring reductions in major adverse cardiovascular events — has the data been published yet, and does it suggest any changes to how clopidogrel dosing or prescribing should be approached based on a patient's genes?
4Clopidogrel is already used for conditions like acute coronary syndrome, peripheral arterial disease, and coronary artery disease — based on what this trial found, would you recommend I get genetic testing before starting or continuing clopidogrel, or is the standard approach still the better option for me right now?
5If this trial showed that genetic differences affect how well clopidogrel works in certain patients, are there alternative blood-thinning medications we should be discussing in case my genetics suggest clopidogrel might not be as effective for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major adverse cardiovascular events (MACE) reductions