Clinical trial NCT00435487: Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Angina, Unstable
Myocardial Infarction
Keywords: Non-ST Elevation Acute Coronary Syndromes coronary interventions
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-15
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
timeFrame: Baseline to Day 30
Secondary outcomes:
measure: Number of Subjects With Stroke
timeFrame: End of hospitalization, Day 30
measure: Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization
timeFrame: End of hospitalization, Day 30
measure: Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days
timeFrame: End of hospitalization, Day 30
measure: Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization
timeFrame: End of hospitalization, Day 30
measure: Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria
timeFrame: End of hospitalization, Day 30
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andra Pradesh
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Coimbatore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Karnataka
country: India
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: