Clopidogrel and Aspirin Together: The Effect on C-Reactive Protein Trial

Coronary Artery Disease Clinical Trial

Official title:

A Single Center, Double-Blind, Randomized Trial to Evaluate the Effects of Aspirin 325 mg + Clopidogrel 75 mg v. Aspirin 325 mg + Placebo on Plasma Concentration of C-Reactive Protein: The CATER Trial Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343876
• Other study ID #: 128-012
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2006
• Last updated: August 20, 2008
• Start date: July 2005
• Est. completion date: November 2006

Study information

• Verified date: August 2008
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Inflammation is associated with worsening outcomes among individuals with CAD; C-reactive protein is a well-known marker of inflammation. Both healthy patients and those with a history of CAD who exhibit elevated CRP are at greater risk for cardiovascular events. Despite CRP's well- documented association with increased risk in the development and progression of CAD, the specific mechanism of elevated CRP in CAD is not known. One possible etiology includes a continuous prothrombotic process associated with CAD. Several studies demonstrate a link between platelet activation and inflammation. If thrombotic processes are involved in the mechanism of elevated CRP, antiplatelet therapy, including clopidogrel, could effectively reduce CRP. Preliminary studies have demonstrated a reduction of CRP with aspirin and a clear association between clopidogrel therapy and reduced CRP, however no randomized trials have been performed. We hypothesize that the proinflammatory effects of platelet activation may be inhibited with combined clopidogrel and aspirin therapy.

Description:

The objective of this trial is to assess the effects of combined therapy of clopidogrel and aspirin versus placebo and aspirin on CRP in patients with known CAD.

Potential subjects already on stable aspirin and statin therapy will be randomized to clopidogrel vs. placebo in a I: 1 design. Participants will undergo study therapy for 3 months. Various laboratory parameters, including serum plasma concentration of CRP, will be assessed throughout the study. The primary endpoint is the effect of study therapy on CRP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Either gender > 18 years of age

• Documented coronary artery disease (CAD) of~ 70% documented lesion

• Must be taking 325 mg/day of aspirin (preferably Ecotrin)and a statin at least 4 weeks prior to enrollment

• The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board

• Able to give informed consent

Exclusion Criteria:

• Documented sensitivity to aspirin or clopidogrel

• Uncontrolled hypertension as determined by the investigator

• Known bleeding disorder or increased risk of bleeding such as: severe hepatic, insufficiency, current peptic ulceration, proliferative diabetic retinopathy, history of bleeding diathesis or coagulopathy

• History of severe systemic bleeding such as: gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage

• Hospitalization for any MI or unstable angina in last 90 days

• Scheduled for a major surgery requiring prolonged study drug cessation (more than 4 weeks)

• Currently taking a thienopyridine agent (clopidogrel or ticlopidine), oral GP IIb/IIIa inhibitor, oral anticoagulant, or dipyridamole

• Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.

• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• aspirin

• clopidogrel

Locations

Country	Name	City	State
United States	LDS Hospital	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Bristol-Myers Squibb, Sanofi-Synthelabo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the observation of the effect of aspirin + clopidogrel vs.
Primary	aspirin + placebo on CRP levels.