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

Sponsored by:	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	Phase III

MedlinePlus related topics: Angina Heart Attack

Drug Information available for: Ticlopidine hydrochloride Ticlopidine Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Safety Events of interest [ Time Frame: Week 12 (on treatment) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Major Adverse Cardiac Events (MACE) and Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: Week 12, 52 (on study) ] [ Designated as safety issue: No ]
Bleeding events [ Time Frame: Week 12, 52 (on treatment) ] [ Designated as safety issue: Yes ]
Adverse Events /Adverse Drug Reactions [ Time Frame: Week 12, 52 (on treatment) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 300 mg as a loading dose, 75 mg once daily as a maintenance dose	Drug: clopidogrel (SR25990) oral administration (tablets)
2: Active Comparator 100 mg twice daily	Drug: ticlopidine oral administration (tablets)

Detailed Description:

After Week 12, one tablet of clopidogrel 75 mg will be administered once daily until Week 52 in a patients' subset(long-term open label phase).

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 meet all of the following criteria:

Myocardial ischemic finding is proven within 1 month 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 is 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

Contacts

Contact: Public Registry ICD

GV-contact-us@sanofi-aventis.com

Locations

Japan
Sanofi-Aventis Administrative Office	Recruiting
Tokyo, Japan
Contact GV-Contact-us@sanofi-aventis.com

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Takaaki Issiki, PhD/FACC

Division of Cardiology, Dpt of Medicine, Teikyo University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC10675
Study First Received:	January 13, 2009
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00821834 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi-Aventis:

Old Myocardial infarction
Platelet Aggregation Inhibitors
Angioplasty

Transluminal
Percutaneous Coronary
Stents

Study placed in the following topic categories:

Heart Diseases
Ticlopidine
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Fibrinolytic Agents
Pain
Cardiovascular Agents
Ischemia

Chest Pain
Signs and Symptoms
Fibrin Modulating Agents
Necrosis
Clopidogrel
Platelet Aggregation Inhibitors
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Ticlopidine
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Angina Pectoris
Vascular Diseases
Fibrinolytic Agents
Pain
Cardiovascular Agents
Ischemia
Pharmacologic Actions

Chest Pain
Signs and Symptoms
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Therapeutic Uses
Clopidogrel
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 06, 2009