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Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

NCT ID: NCT00435487

Last Updated: 2011-10-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Angina, Unstable Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Dalteparin ( Fragmin)

Intervention Type 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.

B

Group Type ACTIVE_COMPARATOR

Unfractionated heparin

Intervention Type 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 \[units per kilogram per hour\]).

Interventions

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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.

Intervention Type DRUG

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 \[units per kilogram per hour\]).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hyderabad, Andhra Pradesh, India

Site Status

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, India

Site Status

Pfizer Investigational Site

Nagpur, Maharashtra, India

Site Status

Pfizer Investigational Site

Pune, Maharashtra, India

Site Status

Pfizer Investigational Site

Pune, Maharashtra, India

Site Status

Pfizer Investigational Site

Ludhiana, Punjab, India

Site Status

Pfizer Investigational Site

Coimbatore, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Karnataka, , India

Site Status

Countries

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India

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6301079&StudyName=Dalteparin%20Versus%20Unfractionated%20Heparin%20In%20Patients%20With%20Acute%20Coronary%20Syndrome

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

Other Identifiers

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A6301079

Identifier Type: -

Identifier Source: org_study_id