Status:

TERMINATED

Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

Lead Sponsor:

Pfizer

Conditions:

Angina, Unstable

Myocardial Infarction

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty ...

Detailed Description

The study was prematurely discontinued on November 30, 2008 due to delay in meeting pre-defined protocol recruitment milestones. There were no safety concerns regarding the study in the decision to te...

Eligibility Criteria

Inclusion

  • Patients more than 18 years
  • Ischemic pain of more than 10 minutes within 24 hours before enrollment
  • At least two of the following three risk factors : Age more than 60 years ( or more than 50 in case of diabetics), Raised cardiac enzyme levels, abnormal ECG findings

Exclusion

  • Contraindications to use of anticoagulants
  • Active bleeding or abnormal coagulation tests
  • Ischemic stroke within last 6 months or hemorrhagic stroke
  • Lumbar or spinal puncture within last 48 hours
  • S creatinine levels more than 2

Key Trial Info

Start Date :

June 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

173 Patients enrolled

Trial Details

Trial ID

NCT00435487

Start Date

June 1 2007

End Date

December 1 2008

Last Update

October 17 2011

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, India, 500 001

2

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, India, 500 034

3

Pfizer Investigational Site

Nagpur, Maharashtra, India, 440 012

4

Pfizer Investigational Site

Pune, Maharashtra, India, 411 001