Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Centre Hospitalier de PAU.
Recruitment status was Recruiting
Recruitment status was Recruiting
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: clopidogrel + aspirin Drug: heparin + clopidogrel + aspirin Drug: enoxaparin + clopidogrel + aspirin Drug: bivalirudin + clopidogrel + aspirin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier de PAU:
Primary Outcome Measures:
- ischaemic events via troponin Ic measurements during 24 hours post procedure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- haemorrhagic events : clinical and biological evaluation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 480 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
group without anticoagulant therapy
|
Drug: clopidogrel + aspirin
Other Name: Plavix Kardégic
|
|
Active Comparator: 2
group with heparin
|
Drug: heparin + clopidogrel + aspirin
Other Name: héparine Choay Plavix Kardégic
|
|
Active Comparator: 3
group with enoxaparin
|
Drug: enoxaparin + clopidogrel + aspirin
Other Name: Lovenox Plavix Kardégic
|
|
Active Comparator: 4
group with bivalirudin
|
Drug: bivalirudin + clopidogrel + aspirin
Other Name: Angiox Plavix Kardégic
|
Detailed Description:
- Background : We don't know if using IV anticoagulant therapy is necessary for percutaneous coronary angioplasty in stable patients.
- Purpose : to compare efficacy and security of use or not of different anticoagulant treatments during percutaneous coronary angioplasty in patients with double antiaggregant therapy.
- Abstract : In stable patients pretreated with double antiaggregant therapy use of IV anticoagulants has not been yet evaluated during angioplasty. In this prospective randomized trial we want to compare in such patients the efficacy and security of the administration of IV heparin, IV enoxaparin, IV bivalirudin and no use of anticoagulant during coronary angioplasty. We will evaluate in each group ischaemic events (clinic, ECG and biology) and haemorrhagic events (clinic, biology) with a one month follow up.
- Primary outcome: ischaemic events via troponin Ic measurements during 24 hours post procedure.
- Secondary outcomes: haemorrhagic events : clinical and biological evaluation (Hb, Ht, TIMI score)
- Study design : monocentric randomized clinical trial type therapeutic equivalence phase IV.
- Interventions : In patients prepared with therapeutic association (aspirin clopidogrel) comparison between use or no of anticoagulant (IV heparin, IV enoxaparin or IV bivalirudin).
- Number of subjects : 120 per group (total of 480).
- Statistical analysis : multivariate analysis with logistic regression models : each end point (troponin Ic increase, haemoglobin decrease, …) will be explicated with treatment group and other covariates (sex, age, creatinine, …).
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- stable angina pectoris or silent ischaemia
Exclusion Criteria:
- instable angina or ACS (Acute Coronary Syndrome)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00669149
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669149
Contacts
| Contact: Nicolas DELARCHE, MD | 55-992-4883 ext 33 | n.delarche@wanadoo.fr |
Locations
| France | |
| Centre Hospitalier de Pau | Recruiting |
| PAU, Pyrénées-Atlantiques, France, 64046 | |
| Contact: Stéphane DEBEUGNY, MD 55-972-6801 ext 33 stephane.debeugny@ch-pau.fr | |
| Principal Investigator: Nicolas DELARCHE, MD | |
| Sub-Investigator: Raphaël LASSERRE, MD | |
Sponsors and Collaborators
Centre Hospitalier de PAU
Investigators
| Principal Investigator: | Nicolas DELARCHE, MD | CH de Pau |
More Information
| Responsible Party: | Stéphane DEBEUGNY, MD, Centre Hospitalier de PAU |
| ClinicalTrials.gov Identifier: | NCT00669149 History of Changes |
| Other Study ID Numbers: | CHPAU 2007/01 |
| Study First Received: | April 25, 2008 |
| Last Updated: | July 1, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier de PAU:
|
ptca antiaggregant therapy anticoagulant therapy |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Ticlopidine Heparin Calcium heparin Clopidogrel Bivalirudin Anticoagulants |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |
ClinicalTrials.gov processed this record on September 27, 2016