Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)
This study is currently recruiting participants.
Verified July 2011 by Centre Hospitalier de PAU
Sponsor:
Centre Hospitalier de PAU
Information provided by:
Centre Hospitalier de PAU
ClinicalTrials.gov Identifier:
NCT00669149
First received: April 25, 2008
Last updated: July 1, 2011
Last verified: July 2011
Tracking Information | |||||
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First Received Date ICMJE | April 25, 2008 | ||||
Last Updated Date | July 1, 2011 | ||||
Start Date ICMJE | June 2008 | ||||
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
ischaemic events via troponin Ic measurements during 24 hours post procedure [ Time Frame: 24 hours ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00669149 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
haemorrhagic events : clinical and biological evaluation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Anticoagulant Treatments and Percutaneous Coronary Angioplasty | ||||
Official Title ICMJE | Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients | ||||
Brief Summary | The purpose of this study is to determine whether adjunction of intravenous anticoagulant therapy (enoxaparin, HNF, bivalirudin) to antiaggregation with clopidogrel and aspirin improves in-hospital results of percutaneous transluminal coronary angioplasty (ptca) in selected patients. |
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Detailed Description |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Coronary Artery Disease | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 480 | ||||
Estimated Completion Date | December 2012 | ||||
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | France | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00669149 | ||||
Other Study ID Numbers ICMJE | CHPAU 2007/01 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Stéphane DEBEUGNY, MD, Centre Hospitalier de PAU | ||||
Study Sponsor ICMJE | Centre Hospitalier de PAU | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Centre Hospitalier de PAU | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |