Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
NCT00435487
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Hyderabad, Andhra Pradesh
- Hyderabad, Andra Pradesh
- Nagpur, Maharashtra
- Pune, Maharashtra
- Pune, Maharashtra
- Ludhiana, Punjab
- Coimbatore, Tamil Nadu
- Karnataka,
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 |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | 173 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |