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Completed

NCT Number: NCT00444132

Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ICCU, Sheba Medical Center

Tel-hashomer, Ramat Gan, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Primary outcomes

  1. Platelet reactivity

Secondary outcomes

  1. recurrent ACS

  2. stroke

  3. death

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Mar 7, 2007
Registry last updated
Sep 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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