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Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Angina, Unstable; Myocardial Infarction

Intervention: Dalteparin ( Fragmin) (Drug); Unfractionated heparin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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)

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30

Secondary outcome:

Number of Subjects With Stroke

Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization

Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days

Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization

Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, Karnataka 560 034, India

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 034, India

Pfizer Investigational Site, Hyderabad, Andra Pradesh 500 001, India

Pfizer Investigational Site, Nagpur, Maharashtra 440 012, India

Pfizer Investigational Site, Pune, Maharashtra 411 001, India

Pfizer Investigational Site, Pune, Maharashtra 411 004, India

Pfizer Investigational Site, Ludhiana, Punjab 141 001, India

Pfizer Investigational Site, Coimbatore, Tamil Nadu 641 014, India

Additional Information

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

Starting date: June 2007
Last updated: October 7, 2011

Page last updated: August 20, 2015

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