Dalteparin vs Unfractionated Heparin In Patients With Acute Coronary Syndrome - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00435487

Purpose

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)

Condition	Intervention	Phase
Angina, Unstable Myocardial Infarction	Drug: Unfractionated heparin Drug: Dalteparin ( Fragmin)	Phase IV

MedlinePlus related topics: Angina Blood Thinners Heart Attack

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Death or non fatal myocardial infarction at end of 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Stroke [ Time Frame: at end of hospitalization and 30 days ] [ Designated as safety issue: Yes ]
Recurrent angina with/without need for hospitalization and/or revascularization, death/non-fatal MI (separately) [ Time Frame: at end of hospitalization and 30 days ] [ Designated as safety issue: Yes ]
Stent thrombosis and abrupt closures during hospitalization [ Time Frame: at end of hospitalization and 30 days ] [ Designated as safety issue: Yes ]
Bleeding at end of hospitalization and 30 days [ Time Frame: at end of hospitalization and 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Active Comparator	Drug: Unfractionated heparin Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg and initial infusion of 12 U/kg/h)
A: Experimental	Drug: Dalteparin ( Fragmin) Dalteparin will be administered at a dose of 120 IU/kg total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435487

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

India
Pfizer Investigational Site	Recruiting
Karnataka, India, 560 034
India, Andhra Pradesh
Pfizer Investigational Site	Recruiting
Hyderabad, Andhra Pradesh, India, 500 034
India, Andra Pradesh
Pfizer Investigational Site	Recruiting
Hyderabad, Andra Pradesh, India, 500 001
India, MAHARASHTRA
Pfizer Investigational Site	Recruiting
Pune, MAHARASHTRA, India, 411 001
India, Maharashtra
Pfizer Investigational Site	Recruiting
Pune, Maharashtra, India, 411 004
Pfizer Investigational Site	Recruiting
Nagpur, Maharashtra, India, 440 012
India, Punjab
Pfizer Investigational Site	Recruiting
Ludhiana, Punjab, India, 141 001
India, Tamil Nadu
Pfizer Investigational Site	Recruiting
Coimbatore, Tamil Nadu, India, 641 014

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6301079
Study First Received:	February 13, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00435487
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

Non-ST Elevation Acute Coronary Syndromes; coronary interventions

Study placed in the following topic categories:

Heart Diseases
Heparin, Low-Molecular-Weight
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Pain
Ischemia
Calcium heparin
Chest Pain

Signs and Symptoms
Necrosis
Dalteparin
Acute Coronary Syndrome
Infarction
Heparin
Myocardial Infarction
Angina, Unstable

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Disease
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Syndrome
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009