Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)
|ClinicalTrials.gov Identifier: NCT00669149|
Recruitment Status : Unknown
Verified July 2011 by Centre Hospitalier de PAU.
Recruitment status was: Recruiting
First Posted : April 29, 2008
Last Update Posted : July 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: clopidogrel + aspirin Drug: heparin + clopidogrel + aspirin Drug: enoxaparin + clopidogrel + aspirin Drug: bivalirudin + clopidogrel + aspirin||Phase 4|
- 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, …).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||December 2012|
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
- ischaemic events via troponin Ic measurements during 24 hours post procedure [ Time Frame: 24 hours ]
- haemorrhagic events : clinical and biological evaluation [ Time Frame: 24 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669149
|Contact: Nicolas DELARCHE, MD||55-992-4883 ext firstname.lastname@example.org|
|Centre Hospitalier de Pau||Recruiting|
|PAU, Pyrénées-Atlantiques, France, 64046|
|Contact: Stéphane DEBEUGNY, MD 55-972-6801 ext 33 email@example.com|
|Principal Investigator: Nicolas DELARCHE, MD|
|Sub-Investigator: Raphaël LASSERRE, MD|
|Principal Investigator:||Nicolas DELARCHE, MD||CH de Pau|