Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00435487
• Other study ID #: A6301079
• Status: Terminated
• Phase: Phase 4
• First received: February 13, 2007
• Last updated: October 7, 2011
• Start date: June 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 173
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Myocardial Infarction

Intervention

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.
• 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]).

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Coimbatore	Tamil Nadu
India	Pfizer Investigational Site	Hyderabad	Andhra Pradesh
India	Pfizer Investigational Site	Hyderabad	Andra Pradesh
India	Pfizer Investigational Site	Karnataka
India	Pfizer Investigational Site	Ludhiana	Punjab
India	Pfizer Investigational Site	Nagpur	Maharashtra
India	Pfizer Investigational Site	Pune	Maharashtra
India	Pfizer Investigational Site	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Day 30	Yes
Secondary	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).	End of hospitalization, Day 30	Yes
Secondary	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.	End of hospitalization, Day 30	Yes
Secondary	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.	End of hospitalization, Day 30	Yes
Secondary	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.	End of hospitalization, Day 30	Yes
Secondary	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%.	End of hospitalization, Day 30	Yes

External Links

•   To obtain contact information for a study center near you, click here.