Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00444132
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 27
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Clopidogrel Non-Responsiveness	Drug: clopidogrel	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
• Study Start Date: Mar 1, 2005
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Platelet reactivity []

Secondary Outcome Measures

1. recurrent ACS []

2. stroke []

3. death []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00444132
• Other Study ID Numbers: SHEBA-05-3621-SM-CTIL
• First Posted: Mar 7, 2007
• Last Update Posted: Sep 20, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: clopidogrel; platelets; acute coronary syndrome; percutaneous coronary intervention
• Additional relevant MeSH terms: Clopidogrel

Study Results

No Results Posted as of Sep 20, 2007