Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS - Full Text View

Sponsor:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00444132

Purpose

Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in patients with coronary artery disease. In the proposed study we wish to prospectively assess the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients who demonstrate non-responsiveness to clopidogrel.

Condition	Intervention	Phase
Clopidogrel Non-Responsiveness	Drug: clopidogrel	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS

Resource links provided by NLM:

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

Platelet reactivity

Secondary Outcome Measures:

recurrent ACS
stroke
death

Estimated Enrollment:	50
Study Start Date:	March 2005
Study Completion Date:	June 2007

Detailed Description:

Prior studies have demonstrated significant variability in platelet response to clopidogrel in patients with coronary artery disease (CAD). Up to 25% of patients have been shown to be non-responders to a conventional dose of clopidogrel. This phenomenon has been associated with higher incidence of recurrent cardiovascular (CVS) adverse events in patients with acute coronary syndrome (ACS), and higher incidence of peri-procedural myocardial damage, thrombotic complications, and ischemic events in patients undergoing elective percutaneous coronary intervention (PCI). Both the ex-vivo anti-platelet effect and the clinical benefit of clopidogrel are dose related. Moreover, in patients sustaining ACS while on maintenance clopidogrel treatment, reloading with 600 mg clopidogrel, resulted in further reduction in platelet aggregation, although the patients were not non-responders. Despite this, the effect of dose escalation has never been examined in patients resistant to clopidogrel. In the present study we wish to assess prospectively the effect of reloading with 600 mg clopidogrel, and double dose maintenance treatment (150 mg/day) for one month in acute myocardial infarction (AMI) patients who demonstrate non-respondese to clopidogrel.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age equal or over 18 years
acute coronary syndrome
Clopidogrel non-responsive
signed an informed consent

Exclusion Criteria:

Bleeding disorder
hypersensitivity to aspirin or clopidogrel
any contraindication to anti-thrombotic or anticoagulant therapy
active neoplastic disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444132

Locations

Israel
ICCU, Sheba Medical Center
Tel-hashomer, Ramat Gan, Israel

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:

Shlomi Matetzky, MD

Senior Physician, ICCU, Sheba Medical Center.

More Information

No publications provided

Study ID Numbers:	SHEBA-05-3621-SM-CTIL
Study First Received:	March 6, 2007
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00444132 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

clopidogrel
platelets
acute coronary syndrome
percutaneous coronary intervention

Additional relevant MeSH terms:

Therapeutic Uses
Clopidogrel
Hematologic Agents
Platelet Aggregation Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009