Back to resultsAnticoagulant Treatments and Percutaneous Coronary Angioplasty (TACA)
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
clopidogrel + aspirin
heparin + clopidogrel + aspirin
enoxaparin + clopidogrel + aspirin
bivalirudin + clopidogrel + aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring ptca, antiaggregant therapy, anticoagulant therapy
Eligibility Criteria
Inclusion Criteria:
- stable angina pectoris or silent ischaemia
Exclusion Criteria:
- instable angina or ACS (Acute Coronary Syndrome)
Sites / Locations
- Centre Hospitalier de Pau
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
group without anticoagulant therapy
group with heparin
group with enoxaparin
group with bivalirudin
Outcomes
Primary Outcome Measures
ischaemic events via troponin Ic measurements during 24 hours post procedure
Secondary Outcome Measures
haemorrhagic events : clinical and biological evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00669149
Brief Title
Anticoagulant Treatments and Percutaneous Coronary Angioplasty
Acronym
TACA
Official Title
Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 3, 2013 (Actual)
Study Completion Date
August 3, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de PAU
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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, …).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
ptca, antiaggregant therapy, anticoagulant therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
group without anticoagulant therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
group with heparin
Arm Title
3
Arm Type
Active Comparator
Arm Description
group with enoxaparin
Arm Title
4
Arm Type
Active Comparator
Arm Description
group with bivalirudin
Intervention Type
Drug
Intervention Name(s)
clopidogrel + aspirin
Other Intervention Name(s)
Plavix Kardégic
Intervention Type
Drug
Intervention Name(s)
heparin + clopidogrel + aspirin
Other Intervention Name(s)
héparine Choay Plavix Kardégic
Intervention Type
Drug
Intervention Name(s)
enoxaparin + clopidogrel + aspirin
Other Intervention Name(s)
Lovenox Plavix Kardégic
Intervention Type
Drug
Intervention Name(s)
bivalirudin + clopidogrel + aspirin
Other Intervention Name(s)
Angiox Plavix Kardégic
Primary Outcome Measure Information:
Title
ischaemic events via troponin Ic measurements during 24 hours post procedure
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
haemorrhagic events : clinical and biological evaluation
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable angina pectoris or silent ischaemia
Exclusion Criteria:
instable angina or ACS (Acute Coronary Syndrome)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas DELARCHE, MD
Organizational Affiliation
CH de Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Pau
City
PAU
State/Province
Pyrénées-Atlantiques
ZIP/Postal Code
64046
Country
France
12. IPD Sharing Statement
Learn more about this trial
Anticoagulant Treatments and Percutaneous Coronary Angioplasty
We'll reach out to this number within 24 hrs