Coronary Artery DiseasePhase 4TAILORNCT01135667
Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI
A Phase 4 study testing clopidogrel and Prasugrel 10 mg in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Lene Holmvang at 1 site in Denmark.
Trial summary
All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before. A cut off value has previously been established. Only low-responders with Multiplate values above the cut off value are included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndromes
- What is being tested?
- clopidogrel and Prasugrel 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Aug 2012
- 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
- PCI with stenting and Multiplate hep-ADP > 70 U despite clopidogrel loading
Who cannot join
- need for vit K antagonist
- women with childbearing potential
- breastfeeding women
- Planned surgery within 6 months
- Intolerance to clopidogrel, prasugrel or aspirin
- previous stroke
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Department of Cardiology, 2013
Copenhagen O, 2100
About this study
Official title: Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention
All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.
A cut off value has previously been established. Only low-responders with Multiplate values above the cut off value are included in the study. The patients are randomized to either clopidogrel 150 mg once daily or Prasugrel 10 mg (age > 75 og bodyweight < 60 kg 5 mg)once daily for 30 days after the procedure.
Read more
Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed.
Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified antiplatelet therapy.
Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major adverse cardiac events (MACE) at 30 days will be collected and reported but the study size does not allow for formal statistical analysis The study ends by the 30 days follow up visit and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study related)
- Being tested
- clopidogrel, Prasugrel 10 mg
- Keywords
- clopidogrel, prasugrel, low responder, multiplate, verify now
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called Plavix
clopidogrel 150 mg once daily for 30 days
Prasugrel 10 mgDrug
Also called Efient
Prasugrel 10 mg once daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| clopidogrel | Active comparator | clopidogrel 150 mg once daily for 30 days (and then 75 mg for additional 11 months - not study related) Receives: Drug: clopidogrel |
| Prasugrel | Active comparator | Prasugrel 10 mg once daily for 30 days (and then clopidogrel 75 mg once daily for additional 11 months - not study related) Receives: Drug: Prasugrel 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heparin ADP by Multiplate
Test of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionAug 2012
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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lene Holmvang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lene Holmvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lene Holmvang, MD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135667
- Sponsor's protocol ID
- TAILOR
- Acronym
- TAILOR
- Status last verified
- Oct 2012
- First submitted
- 23 Apr 2010
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01135667
- Acronym / sponsor ID
- TAILOR / TAILOR
- Keywords
- clopidogrel, prasugrel, low responder, multiplate, verify now
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Lene HolmvangUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Jun 2010 (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.
All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.
A cut off value has previously been established. Only low-responders with Multiplate values above the cut off value are included in the study. The patients are randomized to either clopidogrel 150 mg once daily or Prasugrel 10 mg (age > 75 og bodyweight < 60 kg 5 mg)once daily for 30 days after the procedure.
Follow up will be at 30 days after PCI were another MULTIPLATE test will be performed.
Primary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified antiplatelet therapy.
Clinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major adverse cardiac events (MACE) at 30 days will be collected and reported but the study size does not allow for formal statistical analysis The study ends by the 30 days follow up visit and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study related)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clopidogrel | Active comparator | Drug: clopidogrelclopidogrel 150 mg once daily for 30 days (and then 75 mg for additional 11 months - not study related) |
| Prasugrel | Active comparator | Drug: Prasugrel 10 mgPrasugrel 10 mg once daily for 30 days (and then clopidogrel 75 mg once daily for additional 11 months - not study related) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PCI with stenting and Multiplate hep-ADP > 70 U despite clopidogrel loading
Key exclusion criteria (6 listed)
- need for vit K antagonist
- women with childbearing potential
- breastfeeding women
- Planned surgery within 6 months
- Intolerance to clopidogrel, prasugrel or aspirin
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 |
|---|---|---|
| clopidogrelAlso: Plavixclopidogrel 150 mg once daily for 30 days | Drug | clopidogrel |
| Prasugrel 10 mgAlso: EfientPrasugrel 10 mg once daily for 30 days | Drug | Prasugrel |
Primary outcome
Heparin ADP by Multiplate
Time frame: 30 days
Test of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
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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.
Lene Holmvang, MD study director
Copenhagen University Hospital, Rigshospitalet
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 and Prasugrel 10 mg in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Lene Holmvang at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 4 Oct 2012. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heparin ADP by Multiplate (time frame: 30 days). 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 4 Oct 2012.