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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00821834

Purpose

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	Intervention	Phase
Stable Angina Myocardial Infarction	Drug: clopidogrel (SR25990) Drug: ticlopidine Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Angina Heart Attack

Drug Information available for: Ticlopidine hydrochloride Ticlopidine Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Time from randomization to first safety events of interest [ Time Frame: 12 Weeks (duble blind treatment period) ] [ Designated as safety issue: Yes ]
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) [ Time Frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period) ] [ Designated as safety issue: No ]
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 Frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: No ]
MACCE included:
- All- cause mortality,
- Acute myocardial infarction,
- Revascularization (excluding revascularization related to the planned PCI),
- Stent thrombosis,
- Ischemic stroke.

Enrollment:	1003
Study Start Date:	December 2008
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821834

Locations

Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Takaaki Issiki, PhD/FACC

Division of Cardiology, Dpt of Medicine, Teikyo University

More Information

No publications provided

Responsible Party:	Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00821834 History of Changes
Other Study ID Numbers:	EFC10675
Study First Received:	January 13, 2009
Last Updated:	July 25, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi-Aventis:

Old Myocardial infarction
Platelet Aggregation Inhibitors
Angioplasty

Transluminal
Percutaneous Coronary
Stents

Additional relevant MeSH terms:

Angina Pectoris
Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Ticlopidine
Clopidogrel

Platelet Aggregation Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012