NCT00435487

Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin In High Risk Patients Of Non-ST Elevation Acute Coronary Syndromes Intended For Early Invasive Strategy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 or bypass surgery)

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 terminate the trial.

Conditions

• Angina, Unstable
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Dalteparin ( Fragmin)	Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours.
DRUG	Unfractionated heparin	Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg \[units per kilogram\] and initial infusion of 12 U/kg/h \[units per kilogram per hour\]).

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-02-15
• Last updated: 2011-10-17
• Results posted: 2010-01-27

Locations

8 sites across 1 country: India