Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

NCT00435487 | Terminated Phase 4 Results

• 1 other identifier: A6301079
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 8

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)

Conditions

Angina, Unstable; Myocardial Infarction

Keywords

Non-ST Elevation Acute Coronary Syndromes coronary interventions

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Number of Subjects With Stroke

  End of hospitalization, Day 30

• Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization

  End of hospitalization, Day 30

• 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

• Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization

  End of hospitalization, Day 30

• Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria

  End of hospitalization, Day 30

Study Arms (2)

A

EXPERIMENTAL

Drug: Dalteparin ( Fragmin)

B

ACTIVE COMPARATOR

Drug: Unfractionated heparin

Interventions

Dalteparin ( Fragmin) DRUG

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.

A

Unfractionated heparin DRUG

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 \[units per kilogram per hour\]).

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, 500 001, India

Location

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, 500 034, India

Location

Pfizer Investigational Site

Nagpur, Maharashtra, 440 012, India

Location

Pfizer Investigational Site

Pune, Maharashtra, 411 001, India

Location

Pfizer Investigational Site

Pune, Maharashtra, 411 004, India

Location

Pfizer Investigational Site

Ludhiana, Punjab, 141 001, India

Location

Pfizer Investigational Site

Coimbatore, Tamil Nadu, 641 014, India

Location

Pfizer Investigational Site

Karnataka, 560 034, India

Location

Related Links

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

MeSH Terms

Conditions

Angina, Unstable; Myocardial Infarction

Interventions

Dalteparin; Heparin

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

This study was terminated due to insufficient recruitment of subjects.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 15, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 17, 2011
• Results First Posted: January 27, 2010

Record last verified: 2011-10

Locations

IN (8)