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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)

Primary Purpose

Stable Angina, Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
clopidogrel (SR25990)
ticlopidine
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stable Angina focused on measuring Old Myocardial infarction, Platelet Aggregation Inhibitors, Angioplasty, Transluminal, Percutaneous Coronary, Stents

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clopidogrel

Ticlopidine

Arm Description

Patients received: clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose, ticlopidine matching placebo twice daily.

Patients received: ticlopidine 100 mg twice daily, clopidogrel matching placebo once daily.

Outcomes

Primary Outcome Measures

Time from randomization to first safety events of interest
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

Time from randomization to first Major Adverse Cardiac Events (MACE)
MACE included: All- cause mortality, Acute myocardial infarction, Revascularization (excluding revascularization related to the planned PCI), Stent thrombosis
Time from randomization to first bleeding events
Time from randomization to first Adverse Events / Adverse Drug Reactions
Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE included: All- cause mortality, Acute myocardial infarction, Revascularization (excluding revascularization related to the planned PCI), Stent thrombosis, Ischemic stroke.

Full Information

First Posted
January 13, 2009
Last Updated
July 25, 2011
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00821834
Brief Title
Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned
Acronym
CLEAN
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Myocardial Infarction
Keywords
Old Myocardial infarction, Platelet Aggregation Inhibitors, Angioplasty, Transluminal, Percutaneous Coronary, Stents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1003 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel
Arm Type
Experimental
Arm Description
Patients received: clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose, ticlopidine matching placebo twice daily.
Arm Title
Ticlopidine
Arm Type
Active Comparator
Arm Description
Patients received: ticlopidine 100 mg twice daily, clopidogrel matching placebo once daily.
Intervention Type
Drug
Intervention Name(s)
clopidogrel (SR25990)
Intervention Description
Form: tablets Route: oral
Intervention Type
Drug
Intervention Name(s)
ticlopidine
Intervention Description
Form: tablets Route: oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Form: tablets Route: oral
Primary Outcome Measure Information:
Title
Time from randomization to first safety events of interest
Description
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.
Time Frame
12 Weeks (duble blind treatment period)
Secondary Outcome Measure Information:
Title
Time from randomization to first Major Adverse Cardiac Events (MACE)
Description
MACE included: All- cause mortality, Acute myocardial infarction, Revascularization (excluding revascularization related to the planned PCI), Stent thrombosis
Time Frame
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Title
Time from randomization to first bleeding events
Time Frame
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Title
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)
Title
Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Description
MACCE included: All- cause mortality, Acute myocardial infarction, Revascularization (excluding revascularization related to the planned PCI), Stent thrombosis, Ischemic stroke.
Time Frame
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takaaki Issiki, PhD/FACC
Organizational Affiliation
Division of Cardiology, Dpt of Medicine, Teikyo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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