Coronary Artery DiseasePhase 4TACANCT00669149
Anticoagulant Treatments and Percutaneous Coronary Angioplasty
A Phase 4 study testing clopidogrel + aspirin, heparin + clopidogrel + aspirin and enoxaparin + clopidogrel + aspirin in people with Coronary Artery Disease, run by Centre Hospitalier de PAU at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- clopidogrel + aspirin, heparin + clopidogrel + aspirin and enoxaparin + clopidogrel + aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to 3 Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable angina pectoris or silent ischaemia
Who cannot join
- instable angina or ACS (Acute Coronary Syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients
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.
Read the 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, …).
- Conditions
- Coronary Artery Disease
- Being tested
- clopidogrel + aspirin, heparin + clopidogrel + aspirin, enoxaparin + clopidogrel + aspirin, bivalirudin + clopidogrel + aspirin
- Keywords
- ptca, antiaggregant therapy, anticoagulant therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel + aspirinDrug
Also called Plavix Kardégic
heparin + clopidogrel + aspirinDrug
Also called héparine Choay Plavix Kardégic
enoxaparin + clopidogrel + aspirinDrug
Also called Lovenox Plavix Kardégic
bivalirudin + clopidogrel + aspirinDrug
Also called Angiox Plavix Kardégic
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | group without anticoagulant therapy Receives: Drug: clopidogrel + aspirin |
| 2 | Active comparator | group with heparin Receives: Drug: heparin + clopidogrel + aspirin |
| 3 | Active comparator | group with enoxaparin Receives: Drug: enoxaparin + clopidogrel + aspirin |
| 4 | Active comparator | group with bivalirudin Receives: Drug: bivalirudin + clopidogrel + aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischaemic events via troponin Ic measurements during 24 hours post procedure
Measured: 24 hours
Secondary outcomes (1)
haemorrhagic events : clinical and biological evaluation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startJun 2008
- Primary completion3 Aug 2013
- Study completion3 Aug 2013
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de PAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas DELARCHE, MD, Principal investigator, CH de Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669149
- Sponsor's protocol ID
- CHPAU 2007/01
- Acronym
- TACA
- Status last verified
- May 2019
- First submitted
- 25 Apr 2008
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients
- ClinicalTrials.gov ID
- NCT00669149
- Acronym / sponsor ID
- TACA / CHPAU 2007/01
- Conditions
- Coronary Artery Disease
- Keywords
- ptca, antiaggregant therapy, anticoagulant therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre Hospitalier de PAUUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- 3 Aug 2013 (actual)
- Study completion
- 3 Aug 2013 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, …).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: clopidogrel + aspiringroup without anticoagulant therapy |
| 2 | Active comparator | Drug: heparin + clopidogrel + aspiringroup with heparin |
| 3 | Active comparator | Drug: enoxaparin + clopidogrel + aspiringroup with enoxaparin |
| 4 | Active comparator | Drug: bivalirudin + clopidogrel + aspiringroup with bivalirudin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable angina pectoris or silent ischaemia
Key exclusion criteria (1 listed)
- instable angina or ACS (Acute Coronary Syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrel + aspirinAlso: Plavix Kardégic | Drug | 1 |
| heparin + clopidogrel + aspirinAlso: héparine Choay Plavix Kardégic | Drug | 2 |
| enoxaparin + clopidogrel + aspirinAlso: Lovenox Plavix Kardégic | Drug | 3 |
| bivalirudin + clopidogrel + aspirinAlso: Angiox Plavix Kardégic | Drug | 4 |
Primary outcome
ischaemic events via troponin Ic measurements during 24 hours post procedure
Time frame: 24 hours
1 secondary outcome
haemorrhagic events : clinical and biological evaluation
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas DELARCHE, MD principal investigator
CH de Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clopidogrel + aspirin, heparin + clopidogrel + aspirin and enoxaparin + clopidogrel + aspirin in people with Coronary Artery Disease, run by Centre Hospitalier de PAU at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischaemic events via troponin Ic measurements during 24 hours post procedure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.