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Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

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NCT00435487

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 034 India
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Unstable Angina, Myocardial Infarction
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00435487
Pfizer
Terminated
Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

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[email protected]

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Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
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
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)
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Angina, Unstable
  • Myocardial Infarction
  • 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.
  • 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]).
  • Experimental: A
    Intervention: Drug: Dalteparin ( Fragmin)
  • Active Comparator: B
    Intervention: Drug: Unfractionated heparin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
173
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00435487
A6301079
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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