N/A N=18 Treatment

Clopidogrel Pharmacogenetics (PGX) Bench to Bedside

Metabolism of Clopidogrel

Bottom Line

View on ClinicalTrials.gov: NCT01341600 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Change in Platelet Aggregation Following Therapy With Clopidogrel — 62.9; 68.1; 62.5; 63.2 percentage of aggregation

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Clopidogrel (Drug); Omeprazole/Clopidogrel (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Platelet Aggregation Following Therapy With Clopidogrel	55.0; 37.8; 31.3; 44.2; 33.2; 25.1	—
PRIMARY Change in Platelet Aggregation Following Therapy With Clopidogrel	55.0; 37.8; 31.3; 44.2; 33.2; 25.1	—
SECONDARY Change in Platelet Aggregation Following Therapy With Clopidogrel and Omeprazole	11.6; 27.9; 37.5	—
SECONDARY Level of Active Clopidogrel Metabolite	17.4; 33.3; 32.7; 24.2; 43.8; 53.6	—

Summary

Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and conditions caused by blood clots. Although clopidogrel works in many individuals, some people do not respond as well to this drug. The variation in treatment response may be linked to genetics. This study will examine the effects of clopidogrel in a population in which sequencing for certain genes has been performed in order to determine the role that genes play in the response to various clopidogrel maintenance doses.

Eligibility Criteria

Inclusion Criteria

Amish men or women between 20 and 70 years of age who participated in PAPI

Exclusion Criteria

Severe hypertension (bp > 160/95 mm Hg)
Co-existing malignancy
Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2 times normal
Creatinine >2.0
Hct 50
Thyroid Stimulating Hormone (TSH) 5.50
History of bleeding disorder or gastrointestinal bleeding
History of unstable angina, myocardial infarction (MI), angioplasty, coronary artery bypass surgery
History of atrial fibrillation, stroke or transient ischemic attacks or deep vein thrombosis
Type 2 diabetes
Thrombocytosis (platelet count > 500, 000) or thrombocytopenia (platelet count < 150,000)
Surgery within six months
Clopidogrel allergy
Pregnant women
Currently breast feeding
Omeprazole allergy
Prospective participants taking medications that would affect the outcome(s) to be measured and who cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation, or who are taking vitamins and/or other supplements and who are unwilling to discontinue their use for at least 1 week prior to study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01341600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.