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Completed

NCT Number: NCT00821834

Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned

Primary objective:

* To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned.

Secondary objectives:

* To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine. * To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine. * To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks; * To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

Tokyo, Japan

About this study

The study consisted of two periods:

  • a double blind treatment period of 12 weeks followed by,
  • an open label clopidogrel treatment period in a subset of patients.

All patients should receive aspirin (81-100 mg once daily) as a background therapy during investigational product administration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Stable Angina / Old Myocardial Infarction patients who met all of the following criteria:

  • Myocardial ischemic finding was proven within 2 months before randomization,
  • Either ≥ 75% stenosis documented by CAG or severe stenosis confirmed by multi-slice computerized tomography (MSCT) angiography within 1 month before randomization,
  • PCI was being planned.

Exclusion criteria

  • Planned coronary artery bypass graft (CABG), emergent/urgent PCI, or staged PCI,
  • 3-vessel coronary artery disease with significant lesions in each vessel,
  • Planned PCI associated with 6 or more stent placements,
  • Not less than 50% stenosis of the left main coronary artery,
  • Chronic total occlusion (CTO),
  • Saphenous vein graft (SVG).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

clopidogrel (SR25990)

Drug

Form: tablets

Route: oral

ticlopidine

Drug

Form: tablets

Route: oral

Placebo

Drug

Form: tablets

Route: oral

Primary outcomes

  1. Time from randomization to first safety events of interest

    Time frame: 12 Weeks (duble blind treatment period)

    Safety events of interest were:

    • Clinically significant bleeding,
    • Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction,
    • Elevated liver function values occurring as adverse drug reaction,
    • Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction.

Secondary outcomes

  1. Time from randomization to first Major Adverse Cardiac Events (MACE)

    Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)

    MACE included:

    • All- cause mortality,
    • Acute myocardial infarction,
    • Revascularization (excluding revascularization related to the planned PCI),
    • Stent thrombosis

  2. Time from randomization to first bleeding events

    Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)

  3. Time from randomization to first Adverse Events / Adverse Drug Reactions

    Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)

  4. Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)

    MACCE included:

    • All- cause mortality,
    • Acute myocardial infarction,
    • Revascularization (excluding revascularization related to the planned PCI),
    • Stent thrombosis,
    • Ischemic stroke.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg Once Daily With a 300 mg Loading Dose Versus Ticlopidine 100 mg Twice Daily in Patients With Stable Angina or Old (Healed) Myocardial Infarction to Which Percutaneous Coronary Intervention is Being Planned - With Extended Treatment of Clopidogrel 75 mg Once Daily for 40 Weeks in a Patients' Subset

Acronym: CLEAN

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2009
Registry last updated
Jul 26, 2011

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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