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

NCT00821834 | Completed Phase 3 DMC

• 1 other identifier: EFC10675
• Study Type: interventional
• Target: 1,003
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina; Myocardial Infarction

Keywords

Old Myocardial infarction; Platelet Aggregation Inhibitors; Angioplasty; Transluminal; Percutaneous Coronary; Stents

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Weeks (duble blind treatment period)

Secondary Outcomes (4)

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

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

• Time from randomization to first bleeding events

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

• Time from randomization to first Adverse Events / Adverse Drug Reactions

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

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

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

Study Arms (2)

Clopidogrel

EXPERIMENTAL

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); Drug: Placebo

Ticlopidine

ACTIVE COMPARATOR

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

Drug: ticlopidine; Drug: Placebo

Interventions

clopidogrel (SR25990) DRUG

Form: tablets Route: oral

Clopidogrel

ticlopidine DRUG

Form: tablets Route: oral

Ticlopidine

Placebo DRUG

Form: tablets Route: oral

Clopidogrel; Ticlopidine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Planned coronary artery bypass graft (CABG), emergent/urgent PCI, or staged PCI,
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

MeSH Terms

Conditions

Angina, Stable; Myocardial Infarction

Interventions

Clopidogrel; Ticlopidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Takaaki Issiki, PhD/FACC

  Division of Cardiology, Dpt of Medicine, Teikyo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: December 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 26, 2011

Record last verified: 2011-07

Locations

JP (1)