Efficacy and Safety in Patients With Acute Coronary Syndr... | NCT00325390

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

NCT00325390

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 25, 2009Estimated

Enrollment

800

Phase

Phase 3

Conditions

Platelet Aggregation Inhibitors
NSTEACS

Interventions

clopidogrel (SR25990C)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 11, 2006

First Submission Date that Met QC Criteria

May 11, 2006

First Posted Date

May 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2009

Last Update Posted Date

Mar 25, 2009Estimated

Name	Class
Daiichi Pharmaceuticals	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800

Name	Type	Description	Arm Group Labels	Other Names
clopidogrel (SR25990C)	Drug

Measure	Description	Time Frame
Incidence of effficacy and safety events

Measure	Description	Time Frame
Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events・

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds