NCT01094275

Brief Summary

Clopidogrel, an inhibitor of ADP induced platelet aggregation and activation, is one of the most commonly used drugs in patients with cardiovascular disease. The specific aim of the proposed study is to determine whether the interaction between proton-pump inhibitors (PPIs) and clopidogrel is dependent on CYP2C19 haplotype.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

4.5 years

First QC Date

February 10, 2010

Last Update Submit

January 29, 2018

Conditions

Coronary Artery Disease

Keywords

drug resistancegene polymorphism

Outcome Measures

Primary Outcomes (1)

  • The effect of omeprazole on platelet inhibition by clopidogrel

    To test whether concomitant administration of omeprazole will decrease the platelet inhibitory properties of clopidogrel in subjects with LOF mutation of CYP2C19 (known as \*2 and \*3)

    3 weeks

Secondary Outcomes (1)

  • The effect of omeprazole on the conversion of clopidogrel

    3 weeks

Study Arms (4)

wild / normal type allele of CYP2C gene

clopidogrel 75 mg alone.

Drug: Clopidogrel 75mg, Omeprazole 20mg

wild / normal type allele of CYP2C

clopidogrel 75 mg + omeprazole 20 mg.

Drug: Clopidogrel 75mg, Omeprazole 20mg

Loss of Haplotype CYP2C19

clopidogrel 75mg alone

Drug: Clopidogrel 75mg, Omeprazole 20mg

Loss of function haplotype of CYP2C

clopidogrel 75mg + omerprazole 20mg.

Drug: Clopidogrel 75mg, Omeprazole 20mg

Interventions

Clopidogrel 75mg, Omeprazole 20mgDRUG

Clopidogrel and or Omeprazole as applicable

Also known as: Plavix , Prilosec OTC
Loss of Haplotype CYP2C19Loss of function haplotype of CYP2Cwild / normal type allele of CYP2Cwild / normal type allele of CYP2C gene

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy subjects aged 18-65.

You may qualify if:

  • age 18- 65
  • healthy - not taking any drugs / over the counter drugs regularly.
  • ability and commitment to take the drugs and volunteer for 3 blood draws.

You may not qualify if:

  • Taking any scheduled medication known to affect platelet function such as clopidogrel or NSAIDS11, COX2 inhibitors, beta blockers, calcium channel blockers, diuretics, anti-coagulants, older psychotropic agents, and recent ingestion of alcohol and caffeine
  • Known history of heart disease
  • Bleeding disorders
  • Known allergy or contraindications to omeprazole or clopidogrel
  • Pregnant and nursing women will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Srinivas Nadipalli, Sashidar Guthikonda, Timothy R. DelaO, Ali J. Marian, Federico Monzon, Ping Wang, Neal S. KleimanDOES A LOSS OF FUNCTION POLYMORPHISM OF CYP2C19 MODULATE THE EFFECTS OF CLOPIDOGREL. J Am Coll Cardiol. 2011;57 E1201.

    BACKGROUND

Biospecimen

Retention: NONE RETAINED

Cheek swabs for DNA, blood samples for drug metabolite estimation and platelet function study.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

ClopidogrelOmeprazole

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesBenzimidazoles

Study Officials

  • Neal S Kleiman, MD

    Methodist DeBakey Heart Center.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine Weill Cornell Medical College Medical Director Cardiac Catheterization Laboratories

Study Record Dates

First Submitted

February 10, 2010

First Posted

March 26, 2010

Study Start

January 1, 2010

Primary Completion

June 30, 2014

Study Completion

June 30, 2014

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

US(1)