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

Sponsor:	Intermountain Health Care, Inc.
Collaborators:	Bristol-Myers Squibb Sanofi-Synthelabo
Information provided by:	Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:	NCT00343876

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: aspirin Drug: clopidogrel	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:

The primary endpoint is the observation of the effect of aspirin + clopidogrel vs.
aspirin + placebo on CRP levels.

Estimated Enrollment:	100
Study Start Date:	July 2005
Study Completion Date:	November 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343876

Locations

United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143

Sponsors and Collaborators

Intermountain Health Care, Inc.

Bristol-Myers Squibb

Sanofi-Synthelabo

Investigators

Principal Investigator:

Joseph B Muhlestein, MD

Intermountain Healthcare, LDS Hospital

More Information

No publications provided

Study ID Numbers:	128-012
Study First Received:	June 21, 2006
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00343876 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Intermountain Health Care, Inc.:

hs-CRP
aspirin
clopidogrel

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Arteriosclerosis
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Arterial Occlusive Diseases

Heart Diseases
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Coronary Disease
Analgesics, Non-Narcotic
Clopidogrel
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010