Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation - Full Text View

Sponsor:	Sanofi-Aventis
Collaborator:	Daiichi Pharmaceuticals
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00325390

Purpose

To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome without ST-segment elevation and planned for percutaneous coronary intervention(including stenting).

Condition	Intervention	Phase
Platelet Aggregation Inhibitors NSTEACS	Drug: clopidogrel (SR25990C)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind Parallel Comparison Study of SR25990C Versus Standard Therapy in Japan(Ticlopidine) in Patients With Acute Coronary Syndrome Without ST-Segment Elevation Who Are Planned for Percutaneous Coronary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Incidence of effficacy and safety events

Secondary Outcome Measures:

Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events・

Estimated Enrollment:	800
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged above 20, admitted to hospitals with symptoms suspected to represent an acute coronary syndrome defined as unstable angina or acute MI without ST segment elevation greater than 1 mm are eligible for the study if they meet the following criteria:
- (1)Clinical history consistent with new onset or worsening pattern of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 5 minutes or requiring sublingual nitroglycerin for the relief of pain within 24 hours before registration).
- (2)Patients who meet either of following criteria
  - ECG changes compatible with new ischemia [e.g. ST depression (at least 1 mm), T wave inversion (at least 2 mm), or hyperacute peaked T waves in 2 contiguous leads].
  - already elevated CK at least twice the upper limit of normal or CK-MB or Troponin I or T above the upper limit of normal or positive qualitative test for Troponin T.
- (3)A percutaneous coronary intervention is planned within 96 hours after the first study drug administration

Exclusion Criteria:

A)Factors that affect participation in study:
- (1)Previous disabling stroke
- (2)Previous intracranial hemorrhage or hemorrhagic stroke
- (3)Severe co-morbid condition such that the patient is not expected to survive 1 month
- (4)NYHA Class IV heart failure
- (5)Uncontrolled hypertension
- (6)Requirement for use of oral anticoagulants, non study antiplatelet agents (including ticlopidine) or NSAIDs (excluding unum sumatur), during study period,
B)Factors related to ASA and/or ticlopidine treatment:
- (1)Use of ticlopidine within 1 week prior to randomization
- (2)History of ASA or ticlopidine intolerance or allergy
- (3)Contraindications to ASA or ticlopidine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325390

Locations

Japan
Sanofi-aventis
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Daiichi Pharmaceuticals

Investigators

Study Director:

Yuko HARADA

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	EFC6720
Study First Received:	May 11, 2006
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00325390 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi-Aventis:

SR25990C
Platelet Aggregation Inhibitors
NSTEACS

Additional relevant MeSH terms:

Heart Diseases
Therapeutic Uses
Clopidogrel
Myocardial Ischemia
Hematologic Agents

Acute Coronary Syndrome
Vascular Diseases
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010