Current partner codePEPTIDESDE
NCT00669149·Phase 4·INTERVENTIONAL

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

clopidogrel + aspirin

DRUG

heparin + clopidogrel + aspirin

DRUG

enoxaparin + clopidogrel + aspirin

DRUG

bivalirudin + clopidogrel + aspirin

Timeline

From registration to results.

  1. First posted

    Apr 29, 2008

  2. Study start

    Jun 2008

  3. Primary completion

    Aug 3, 2013

  4. Study completion

    Aug 3, 2013

  5. Results posted

    Not reported

  6. 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.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.