Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

Phase 4

Terminated

• Conditions: Angina, Unstable; Myocardial Infarction
• Interventions: Drug: Dalteparin ( Fragmin); Drug: Unfractionated heparin

• Registration Number: NCT00435487
• Lead Sponsor: Pfizer

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 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.

Study Timeline

• Study First Submitted: 2007-02-13
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-15
• Study Start: 2007-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-22
• Results First Submitted QC: 2009-12-22
• Results First Posted: 2010-01-27
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 173

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Dalteparin ( Fragmin)	-
B	Unfractionated heparin	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30	Baseline to Day 30	Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Stroke	End of hospitalization, Day 30	Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma).
Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization	End of hospitalization, Day 30	Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization.
Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days	End of hospitalization, Day 30	Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.
Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization	End of hospitalization, Day 30	Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically.
Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria	End of hospitalization, Day 30	Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇳 Karnataka, India