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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Platelet Aggregation Inhibitors; NSTEACS

Intervention: clopidogrel (SR25990C) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Yuko HARADA, Study Director, Affiliation: Sanofi

Summary

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: Incidence of effficacy and safety events

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

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Sanofi-Aventis, Tokyo, Japan
Additional Information

Starting date: July 2004
Last updated: March 24, 2009

Page last updated: August 23, 2015

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