Anticoagulant Treatments and Percutaneous Coronary Angioplasty
Information source: Centre Hospitalier de PAU
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: clopidogrel + aspirin (Drug); heparin + clopidogrel + aspirin (Drug); enoxaparin + clopidogrel + aspirin (Drug); bivalirudin + clopidogrel + aspirin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Centre Hospitalier de PAU Official(s) and/or principal investigator(s):
Nicolas DELARCHE, MD, Principal Investigator, Affiliation: CH de Pau
Overall contact:
Nicolas DELARCHE, MD, Phone: 55-992-4883, Ext: 33, Email: n.delarche@wanadoo.fr
Summary
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.
Clinical Details
Official title: Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: ischaemic events via troponin Ic measurements during 24 hours post procedure
Secondary outcome: haemorrhagic events : clinical and biological evaluation
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- stable angina pectoris or silent ischaemia
Exclusion Criteria:
- instable angina or ACS (Acute Coronary Syndrome)
Locations and Contacts
Nicolas DELARCHE, MD, Phone: 55-992-4883, Ext: 33, Email: n.delarche@wanadoo.fr
Centre Hospitalier de Pau, PAU, Pyrénées-Atlantiques 64046, France; Recruiting
Stéphane DEBEUGNY, MD, Phone: 55-972-6801, Ext: 33, Email: stephane.debeugny@ch-pau.fr
Nicolas DELARCHE, MD, Principal Investigator
Raphaël LASSERRE, MD, Sub-Investigator
Additional Information
Starting date: June 2008
Ending date: September 2009
Last updated: January 8, 2009
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