DRUG
Anticoagulant Treatments and Percutaneous Coronary Angioplasty
Status
Terminated
Phase
Phase 4
Enrollment
99
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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, …).
Interventions
Treatment arms and agents.
DRUG
heparin + clopidogrel + aspirin
DRUG
enoxaparin + clopidogrel + aspirin
DRUG
bivalirudin + clopidogrel + aspirin
Timeline
From registration to results.
First posted
Apr 29, 2008
Study start
Jun 2008
Primary completion
Aug 3, 2013
Study completion
Aug 3, 2013
Results posted
Not reported
Registry updated
May 17, 2019
Outcomes
What the study measures.
Primary outcomes
ischaemic events via troponin Ic measurements during 24 hours post procedure
Time frame · 24 hours
Secondary outcomes
haemorrhagic events : clinical and biological evaluation
Time frame · 24 hours
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * stable angina pectoris or silent ischaemia Exclusion Criteria: * instable angina or ACS (Acute Coronary Syndrome)
Study locations
1 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
Centre Hospitalier de Pau
Pau, Pyrénées-Atlantiques, France
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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