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

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ClinicalTrials.gov Identifier: NCT00821834
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
Sanofi

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Stable Angina Myocardial Infarction Drug: clopidogrel (SR25990) Drug: ticlopidine Drug: Placebo Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1003 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : December 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina Heart Attack

Arm Intervention/treatment
Experimental: Clopidogrel

Patients received:

  • clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose,
  • ticlopidine matching placebo twice daily.
Drug: clopidogrel (SR25990)

Form: tablets

Route: oral


Drug: Placebo

Form: tablets

Route: oral


Active Comparator: Ticlopidine

Patients received:

  • ticlopidine 100 mg twice daily,
  • clopidogrel matching placebo once daily.
Drug: ticlopidine

Form: tablets

Route: oral


Drug: Placebo

Form: tablets

Route: oral





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821834


Locations
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Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
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Principal Investigator: Takaaki Issiki, PhD/FACC Division of Cardiology, Dpt of Medicine, Teikyo University

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Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00821834     History of Changes
Other Study ID Numbers: EFC10675
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Sanofi:
Old Myocardial infarction
Platelet Aggregation Inhibitors
Angioplasty
Transluminal
Percutaneous Coronary
Stents

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Angina Pectoris
Angina, Stable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors