NCT00444132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

March 6, 2007

Last Update Submit

September 19, 2007

Conditions

Clopidogrel Non-Responsiveness

Keywords

clopidogrelplateletsacute coronary syndromepercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • Platelet reactivity

Secondary Outcomes (3)

  • recurrent ACS

  • stroke

  • death

Interventions

clopidogrelDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICCU, Sheba Medical Center

Tel-hashomer, Ramat Gan, Israel

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Shlomi Matetzky, MD

    Senior Physician, ICCU, Sheba Medical Center.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 7, 2007

Study Start

March 1, 2005

Study Completion

June 1, 2007

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

IL(1)