Coronary Artery DiseasePhase 3TRIPLETE RESETNCT01543932
High Clopidogrel Dose Versus Prasugrel and Ticagrelor in High Reactive Stable Patients
A Phase 3 study testing Clopidogrel, Prasugrel and Ticagrelor in people with Coronary Artery Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Dual antiplatelet therapy with Aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s) implantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel, Prasugrel and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Dec 2013
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients underwent to percutaneous coronary intervention (PCI)
- clopidogrel resistance after Platelet reactivity blood test
Who cannot join
- history of bleeding diathesis
- chronic oral anticoagulation treatment
- contraindications to antiplatelet therapy
- PCI or coronary artery bypass grafting (CABG) < 3 months
- hemodynamic instability
- platelet count < 100,000/μl
Show all 12Show fewer
- hematocrit < 30%
- creatinine clearance < 25 ml/min
- Patients with a history of stroke
- contraindication for prasugrel administration
- patients weighing < 60 kg
- > 75 years of age.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept.of Cardiovascular Sciences,Policlinico Umberto I
Rome, Rome, 000161
About this study
Official title: Comparison of Therapy With TICAGRELOR, Prasugrel and High Clopidogrel Dose in PCI Patients With High on Treatment Platelet Reactivity and Genotype Variation
Dual antiplatelet therapy with Aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s) implantation. Interindividual variability in platelet response to Clopidogrel has been reported, with several mechanisms (intrinsic high platelet reactivity [PR], variability of the drug metabolism, and various drug interactions) being implicated for high post-Clopidogrel treatment PR. The investigators aim to perform a prospective, single-center, investigator-initiated, randomized, study to compare platelet inhibition by Prasugrel 10 mg/day, Ticagrelor (90 mg twice daily) and high-dose 150 mg/day Clopidogrel in patients with High on-treatment platelet reactivity (HTPR) with standard dose of Clopidogrel. Patients with HTPR (defined as area under curve-AUC ≥ 450 or > 45 Unit) and with loss-of-function allele CYP2C19*2 will be enrolled in the study and will be randomized (Day 0) in a 1:1:1 ratio, to either Clopidogrel 150 mg a day or Prasugrel 10 mg a day or Ticagrelor (90 mg twice daily) until Day-15 and-30 post randomization.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel, Prasugrel, Ticagrelor
- Keywords
- antiplatelet effect, prasugrel, clopidogrel, stable angina
- Medical subject headings
- Coronary Artery Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Patient will be randomized to this intervention will receive in the first time the double dose of clopidogrel and after 15 days and 30 days we will control the responsivness of the study drug.
PrasugrelDrug
Patient will be randomized to this intervention will receive in the first time prasugrel and after 15 days and 30 days we will control the responsivness of the study drug.
TicagrelorDrug
Patient will be randomized to this intervention will receive in the first time Ticagrelor and after 14 days and 28 days we will change their therapy with the high clopidogrel dose or Prasugrel (dual crossover).
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel standard dose | Experimental | Patient will be randomized to this intervention will receive in the first time prasugrel and after 15 days and 30 days we will control the responsivness of the study drug. Receives: Drug: Prasugrel |
| high clopidogrel dose | Experimental | Patient will be randomized to this intervention will receive in the first time the high clopidogrel dose and after 15 days and 30 days we will control the responsivness of the study drug. Receives: Drug: Clopidogrel |
| Ticagrelor standard dose | Experimental | Patient will be randomized to this intervention will receive in the first time ticagrelor and after 15 days and 30 days we will control the responsivness of the study drug. Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
antiplatelet effect of standard dose of prasugrel or ticagrelor versus high dose clopidogrel in stable patients with high reactivity
the antiplatelet effect in terms of level platelet reactivity (< 450 Area under the curve (AU*min)) of standard dose of Prasugrel (10 mg/day) either Ticagrelor (90 mg twice daily) versus high dose Clopidogrel (150 mg/day) in patients undergoing PCI with high reactivity
Measured: 30 days
Secondary outcomes (2)
Bleeding (major, minor, or minimal)
Bleeding (major, minor, or minimal)
Measured: 45 days
Major Adverse Cardiac Cerebrovascular Events
cardiovascular death, myocardial infarction, and stroke
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Sardella, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543932
- Sponsor's protocol ID
- TRIPLETE RESET
- Acronym
- TRIPLETE RESET
- Status last verified
- Dec 2013
- First submitted
- 21 Feb 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sardella G, Calcagno S, Mancone M, Lucisano L, Pennacchi M, Stio RE, Placentino F, Di Roma A, Cavallo E, Palmirotta R, Guadagni F, Fedele F. Comparison of therapy with Ticagrelor, Prasugrel or high Clopidogrel dose in PCI patients with high on treatment platelet reactivity and genotype variation. TRIPLETE RESET trial. Int J Cardiol. 2015 Sep 1;194:60-2. doi: 10.1016/j.ijcard.2015.05.085. Epub 2015 May 15. No abstract available.
PubMed 26011265
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapy With TICAGRELOR, Prasugrel and High Clopidogrel Dose in PCI Patients With High on Treatment Platelet Reactivity and Genotype Variation
- ClinicalTrials.gov ID
- NCT01543932
- Acronym / sponsor ID
- TRIPLETE RESET / TRIPLETE RESET
- Conditions
- Coronary Artery Disease
- Keywords
- antiplatelet effect, prasugrel, clopidogrel, stable angina
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Mar 2012 (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.
Dual antiplatelet therapy with Aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s) implantation. Interindividual variability in platelet response to Clopidogrel has been reported, with several mechanisms (intrinsic high platelet reactivity [PR], variability of the drug metabolism, and various drug interactions) being implicated for high post-Clopidogrel treatment PR. The investigators aim to perform a prospective, single-center, investigator-initiated, randomized, study to compare platelet inhibition by Prasugrel 10 mg/day, Ticagrelor (90 mg twice daily) and high-dose 150 mg/day Clopidogrel in patients with High on-treatment platelet reactivity (HTPR) with standard dose of Clopidogrel. Patients with HTPR (defined as area under curve-AUC ≥ 450 or > 45 Unit) and with loss-of-function allele CYP2C19*2 will be enrolled in the study and will be randomized (Day 0) in a 1:1:1 ratio, to either Clopidogrel 150 mg a day or Prasugrel 10 mg a day or Ticagrelor (90 mg twice daily) until Day-15 and-30 post randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prasugrel standard dose | Experimental | Drug: PrasugrelPatient will be randomized to this intervention will receive in the first time prasugrel and after 15 days and 30 days we will control the responsivness of the study drug. |
| high clopidogrel dose | Experimental | Drug: ClopidogrelPatient will be randomized to this intervention will receive in the first time the high clopidogrel dose and after 15 days and 30 days we will control the responsivness of the study drug. |
| Ticagrelor standard dose | Experimental | Drug: TicagrelorPatient will be randomized to this intervention will receive in the first time ticagrelor and after 15 days and 30 days we will control the responsivness of the study drug. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients underwent to percutaneous coronary intervention (PCI)
- clopidogrel resistance after Platelet reactivity blood test
Key exclusion criteria (12 listed)
- history of bleeding diathesis
- chronic oral anticoagulation treatment
- contraindications to antiplatelet therapy
- PCI or coronary artery bypass grafting (CABG) < 3 months
- hemodynamic instability
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 |
|---|---|---|
| ClopidogrelPatient will be randomized to this intervention will receive in the first time the double dose of clopidogrel and after 15 days and 30 days we will control the responsivness of the study drug. | Drug | high clopidogrel dose |
| PrasugrelPatient will be randomized to this intervention will receive in the first time prasugrel and after 15 days and 30 days we will control the responsivness of the study drug. | Drug | Prasugrel standard dose |
| TicagrelorPatient will be randomized to this intervention will receive in the first time Ticagrelor and after 14 days and 28 days we will change their therapy with the high clopidogrel dose or Prasugrel (dual crossover). | Drug | Ticagrelor standard dose |
Primary outcome
antiplatelet effect of standard dose of prasugrel or ticagrelor versus high dose clopidogrel in stable patients with high reactivity
Time frame: 30 days
the antiplatelet effect in terms of level platelet reactivity (< 450 Area under the curve (AU*min)) of standard dose of Prasugrel (10 mg/day) either Ticagrelor (90 mg twice daily) versus high dose Clopidogrel (150 mg/day) in patients undergoing PCI with high reactivity
2 secondary outcomes
Bleeding (major, minor, or minimal)
Time frame: 45 days
Major Adverse Cardiac Cerebrovascular Events
Time frame: 45 days
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 11 Dec 2013.
- Derived from this study: PubMed 26011265Sardella G, Calcagno S, Mancone M, Lucisano L, Pennacchi M, Stio RE, Placentino F, Di Roma A, Cavallo E, Palmirotta R, Guadagni F, Fedele F. Comparison of therapy with Ticagrelor, Prasugrel or high Clopidogrel dose in PCI patients with high on treatment platelet reactivity and genotype variation. TRIPLETE RESET trial. Int J Cardiol. 2015 Sep 1;194:60-2. doi: 10.1016/j.ijcard.2015.05.085. Epub 2015 May 15. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel, Prasugrel and Ticagrelor in people with Coronary Artery Disease, run by University of Roma La Sapienza at 1 site in Italy.
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 2 inclusion and 12 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 11 Dec 2013. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
antiplatelet effect of standard dose of prasugrel or ticagrelor versus high dose clopidogrel in stable patients with high reactivity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543932, which also lists 1 linked publication.
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 11 Dec 2013.