Anticoagulant Treatments and Percutaneous Coronary Angioplasty
NCT ID: NCT00669149
Last Updated: 2019-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
99 participants
INTERVENTIONAL
2008-06-30
2013-08-03
Brief Summary
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Detailed Description
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* 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, …).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
group without anticoagulant therapy
clopidogrel + aspirin
2
group with heparin
heparin + clopidogrel + aspirin
3
group with enoxaparin
enoxaparin + clopidogrel + aspirin
4
group with bivalirudin
bivalirudin + clopidogrel + aspirin
Interventions
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clopidogrel + aspirin
heparin + clopidogrel + aspirin
enoxaparin + clopidogrel + aspirin
bivalirudin + clopidogrel + aspirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Centre Hospitalier de PAU
OTHER
Responsible Party
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Principal Investigators
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Nicolas DELARCHE, MD
Role: PRINCIPAL_INVESTIGATOR
CH de Pau
Locations
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Centre Hospitalier de Pau
Pau, Pyrénées-Atlantiques, France
Countries
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Other Identifiers
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CHPAU 2007/01
Identifier Type: -
Identifier Source: org_study_id
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