Studying the Efficacy of Aspirin & Clopidogrel in Healthy Subjects With Stable Coronary Artery Disease.

NCT01011257 | Withdrawn Phase 4

• 1 other identifier: Pro00001863
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the hypothesis that aspirin or clopidogrel taken twice daily will augment their antiplatelet efficacy in patients with an elevated platelet turnover (as measured by the proportion of reticulated (young) platelets) compared with once daily dosing.

Conditions

Coronary Artery Disease

Keywords

CAD

Outcome Measures

Primary Outcomes (1)

• To look if dual dosing of aspirin and/or clopidogrel will augment antiplatelet efficacy in patients with elevated reticulated platelet turnover.

  1 year

Study Arms (2)

Aspirin 81 mg, 1 tab twice daily

ACTIVE COMPARATOR

All participants to take one aspirin (81mg per tab) twice daily.

Drug: Asprin

Clopidogrel 75 mg 1 tab daily

ACTIVE COMPARATOR

Only stable CAD participants will take Clopidogrel (75mg per tab) daily.

Drug: Clopidogrel

Interventions

Asprin DRUG

asprin 81mg, 1 tab, twice daily OR aspirin 81mg, 2 tab, once daily

Also known as: ASA

Aspirin 81 mg, 1 tab twice daily

Clopidogrel DRUG

clopidogrel 75 mg bid

Also known as: Plavix

Clopidogrel 75 mg 1 tab daily

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Group A: Healthy subjects aged 18-64 years with no evidence of coronary artery disease or any major risk factors for CAD including smoking, diabetes mellitus, hyperlipidemia, hypertension and obesity.
• Group B: Patients with known CAD aged 18-64 years taking aspirin 81 mg daily as the only antiplatelet therapy. Patients should be in stable condition and at least one month post myocardial infarction.
• Group C: Patients with known stable CAD aged 18-64 years taking aspirin 81 mg and clopidogrel 75 mg daily. Patients should be in stable condition and at least one month post myocardial infarction.

You may not qualify if:

• Subjects will be excluded if they used NSAID's within one week prior to the study, have renal insufficiency, inflammatory disorders such as rheumatologic conditions, autoimmune disorders, active infections, malignancy or if they are undergoing chemotherapy.
• We will also exclude patients with unstable angina and recent (less than a month) CABG or PCTA.

Sponsors & Collaborators

• Neil Kleiman, MD: lead

Study Sites (1)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

acetylsalicylic acid lysinate; 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

• Neal S Kleiman, MD

  Methodist DeBakey Heart Center.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)