Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

NCT00435487

Last updated date
Study Location
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 034, India
Contact
1-800-718-1021

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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

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Unstable Angina, Myocardial InfarctionDalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
NCT00435487
  1. Hyderabad, Andhra Pradesh
  2. Hyderabad, Andra Pradesh
  3. Nagpur, Maharashtra
  4. Pune, Maharashtra
  5. Pune, Maharashtra
  6. Ludhiana, Punjab
  7. Coimbatore, Tamil Nadu
  8. Karnataka,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
Official Title  ICMJE 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
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)
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Angina, Unstable
  • Myocardial Infarction
Intervention  ICMJE
  • 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]).
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Dalteparin ( Fragmin)
  • Active Comparator: B
    Intervention: Drug: Unfractionated heparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 22, 2009)
173
Original Enrollment  ICMJE
 (submitted: February 14, 2007)
400
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00435487
Other Study ID Numbers  ICMJE A6301079
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP