Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Angina, Unstable; Myocardial Infarction

Treatments: Drug: Unfractionated heparin; Drug: Dalteparin ( Fragmin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435487

A6301079

Details and patient eligibility

About

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 or bypass surgery)

Full 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 terminate the trial.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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173 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Dalteparin ( Fragmin)

B

Active Comparator group

Treatment:

Drug: Unfractionated heparin