Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

Dalteparin ( Fragmin)

Unfractionated heparin

About this trial

This is an interventional treatment trial for Angina, Unstable focused on measuring Non-ST Elevation Acute Coronary Syndromes coronary interventions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up 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

Number of Subjects With Stroke

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

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

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

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

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%.

Full Information

NCT ID

NCT00435487

First Posted

February 13, 2007

Last Updated

October 7, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00435487

Brief Title

Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

June 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angina, Unstable, Myocardial Infarction

Keywords

Non-ST Elevation Acute Coronary Syndromes coronary interventions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

173 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm Title

B

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Dalteparin ( Fragmin)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Unfractionated heparin

Intervention Description

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]).

Primary Outcome Measure Information:

Title

Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30

Description

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.

Time Frame

Baseline to Day 30

Secondary Outcome Measure Information:

Title

Number of Subjects With Stroke

Description

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).

Time Frame