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Trial record 1 of 1 for:    NCT00435487
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Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT00435487
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : February 15, 2007
Results First Posted : January 27, 2010
Last Update Posted : October 17, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 13, 2007
First Posted Date  ICMJE February 15, 2007
Results First Submitted Date  ICMJE December 22, 2009
Results First Posted Date  ICMJE January 27, 2010
Last Update Posted Date October 17, 2011
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30 [ Time Frame: Baseline 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2007)
Death or non fatal myocardial infarction at end of 30 days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
  • Number of Subjects With Stroke [ Time Frame: End of hospitalization, Day 30 ]
    Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma).
  • Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization [ Time Frame: End of hospitalization, Day 30 ]
    Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization.
  • Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days [ Time Frame: End of hospitalization, Day 30 ]
    Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.
  • Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization [ Time Frame: End of hospitalization, Day 30 ]
    Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically.
  • Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria [ Time Frame: End of hospitalization, Day 30 ]
    Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2007)
Stroke Recurrent angina with/without need for hospitalization and/or revascularization, death/non-fatal MI (separately) Stent thrombosis and abrupt closures during hospitalizalization Bleeding at end of hospitalizalization and 30 days
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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