Anticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)
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ClinicalTrials.gov Identifier: NCT00669149 |
Recruitment Status :
Terminated
(recruitment difficulties)
First Posted : April 29, 2008
Last Update Posted : May 17, 2019
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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) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | August 3, 2013 |
Actual Study Completion Date : | August 3, 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
group without anticoagulant therapy
|
Drug: clopidogrel + aspirin
Other Name: Plavix Kardégic |
Active Comparator: 2
group with heparin
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Drug: heparin + clopidogrel + aspirin
Other Name: héparine Choay Plavix Kardégic |
Active Comparator: 3
group with enoxaparin
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Drug: enoxaparin + clopidogrel + aspirin
Other Name: Lovenox Plavix Kardégic |
Active Comparator: 4
group with bivalirudin
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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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- stable angina pectoris or silent ischaemia
Exclusion Criteria:
- instable angina or ACS (Acute Coronary Syndrome)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669149
France | |
Centre Hospitalier de Pau | |
PAU, Pyrénées-Atlantiques, France, 64046 |
Principal Investigator: | Nicolas DELARCHE, MD | CH de Pau |
Responsible Party: | Centre Hospitalier de PAU |
ClinicalTrials.gov Identifier: | NCT00669149 |
Other Study ID Numbers: |
CHPAU 2007/01 |
First Posted: | April 29, 2008 Key Record Dates |
Last Update Posted: | May 17, 2019 |
Last Verified: | May 2019 |
ptca antiaggregant therapy anticoagulant therapy |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Heparin Enoxaparin Bivalirudin Clopidogrel 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 Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists |