Pilot Study on the Effect of High Clopidogrel Maintenance Dosing

NCT01118793 | Completed

• 2 other identifiers: HSC# 08-50831UL1RR025774-01
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Scripps pilot study on the effect of high clopidogrel maintenance dosing and its relationship to cytochrome P450 2C19 polymorphism status \[STSI/CTSA\].

Conditions

Coronary Artery Disease

Study Arms (1)

double dosing of Clopidogrel

This is a Scripps pilot study on the effect of high clopidogrel maintenance dosing and its relationship to cytochrome P450 2C19 polymorphism status \[STSI/CTSA\].

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

150 mg dosage of Clopidogrel for 7 to 10 days.

Also known as: Plavix

double dosing of Clopidogrel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Scripps Health patients having decresed platlet inhibition on clopidogrel

You may qualify if:

• Males and non-pregnant females between the ages of 18-85.
• Patients able to give informed written consent.
• Patients on clopidogrel for ≥ 7 days.

You may not qualify if:

• Participation in a study of experimental therapy or device within prior 30 days.
• Pregnant women or women of childbearing potential not using an acceptable method of contraception who have not been proven to have a negative pregnancy test result.
• Inability to comply with all aspects of the protocol.
• History of bleeding diathesis or evidence of active abnormal bleeding within previous 90 days.
• Severe hypertension (systolic blood pressure \> 200 mm Hg or diastolic blood pressure \> 110 mm Hg) not adequately controlled on antihypertensive therapy.
• Major surgery within the preceding 6 weeks.
• History of stroke within 30 days or any history of hemorrhagic stroke.
• History of intracranial neoplasm.
• Current or planned administration of another parenteral GP IIb-IIIa inhibitor within 7 days of enrollment.
• Known hypersensitivity to any component of the product.
• Unstable angina with dynamic ST or T wave changes within 48 hours of enrollment.
• Administration of LMWH within 8 hours prior to enrollment or UFH within 60 minutes unless a PPT \< 50 secs or ACT \< 150 secs.
• On chronic anticoagulation (i.e. Coumadin).
• Hemoglobin \< 10 g/dL.
• Hematocrit \< 30%.

Sponsors & Collaborators

• Scripps Health: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Scripp Health

La Jolla, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Colin Barker, MD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

US (1)