E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-ST elevation acute coronary syndrome (coronary artery disease) |
Non-ST segment elevatie acuut coronair syndroom (coronairlijden) |
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E.1.1.1 | Medical condition in easily understood language |
Coronary artery disease |
Coronairlijden |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary efficacy endpoint is to assess ischemic risk of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients.
The primary safety endpoint is to assess bleeding risk of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients.
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Het primair effectiviteits eindpunt beoordeelt ischemisch risico van genotype-geleide clopidogrel monotherapie gedurende de eerste 6 maanden na succesvolle PCI in NSTE-ACS patienten.
Het primaire veiligheidseindpunt beoordeelt bloedingsrisico in genotype-geleide clopidogrel monotherapie gedurende de eerste 6 maanden na succesvolle PCI in NSTE-ACS patienten. |
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E.2.2 | Secondary objectives of the trial |
The secondary endpoints include the individual components of the primary safety and efficacy endpoints (at 3 and 6 months). |
De secundaire eindpunten bestaan uit de individuele componenten uit de primaire veiligheids- en effectiviteitseindpunten op 3 en 6 maanden. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met: - Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina) - Successful PCI (according to the treating physician) with implantation of new generation drugeluting stents. - CYP2C19 extensive metabolizer
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- 18 jaar of ouder - Klinische diagnose van NSTE-ACS (NSTEMI of instabiele AP) - Succesvolle PCI (volgens behandelend arts) met implantatie van nieuwe generatie drugeluting stents - CYP2C19 extensive metabolizer |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Known allergy or contraindication for aspirin or clopidogrel. - Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation) - Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS) - High-risk features for PCI including left main disease, chronic total occlusion, bifurcation lesion requiring 2-stent treatment, saphenous or arterial graft lesion, severely calcified lesion requiring the use of the Rotablator system, ≥3 treated vessels, ≥ 3 stents implanted and total stent length >60 mm. - Recent stroke, transient ischemic attack (TIA) or intracranial bleeding - Severe hepatic impairment - Planned surgical intervention within 12 months of PCI - Pregnant or breastfeeding women at time of enrolment - Participation in another trial with an investigational drug or device • Patients requiring staged procedure (to avoid heterogeneity in the duration of pharmacological treatment between index and staged procedures)
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- Bekende allergie of contraindicatie voor aspirine of clopidogrel - Gelijktijdig gebruik van orale antistolling - Bestaande indicatie voor duale antiplaatjestherapie bij opname - Hoog risico eigenschappen van de PCI, waaronder aangedane hoofdstam, CTO, bifurcatie laesie waarvoor 2 stents, arteriele of v. saphenica graft, ernstig verkalkte laesie waarvoor rotablatie, ≥3 behandelde vaten, ≥ 3 stents geimplanteerd, totale stent lengte >60 mm - Recente CVA, TIA of intracraniele bloeding - Ernstige leverinsufficientie - Geplande chirurgische interventie <12 maanden na PCI - Zwanger of borstvoeding ten tijden van deelname - Deelname in een andere interventiestudie - Patienten die een geplande revascularisatie hebben voor rest laesies |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary ischemic endpoints at 6 months is the composite of: • All-cause mortality • Myocardial infarction • Academic Research Consortium (ARC) defined definite or probable stent thrombosis • Ischemic stroke
The primary bleeding endpoint at 6 months is: • Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding
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Primair ischemisch eindpunt op 6 maanden is een composiet van all-cause mortaliteit, myocardinfarct, definite or probable stent trombose en ischemisch CVA.
Primair bloedingseindpunt op 6 maanden is major or minor bloeding |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints will include: • Primary ischemic and bleeding endpoint at 3 months • Each individual component of the primary endpoints at 3 and 6 months • Cardiovascular mortality at 3 and 6 months • Non-cardiovascular mortality at 3 and 6 months • Any need for revascularization at 3 and 6 months • Any periprocedural complications
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- Primair ischemisch en bloedingseindpunt op 3 maanden - Alle individuele componenten van de primaire eindpunten op 3 en 6 maanden - CV mortaliteit op 3 en 6 maanden - Non-CV mortaliteit op 3 en 6 maanden - Revascularisatie op 3 en 6 maanden - Periprocedurele complicaties |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 and 6 months |
3 en 6 maanden |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS
Premature termination of the study in case of more than 3 stent thromboses in the genotype-guided clopidogrel monotherapy patients within 6 months of the index procedure and there are no signs of non-adherence to medication, recruitment will be prematurely halted. Patients on clopidogrel monotherapy will be switched to guideline-directed therapy. |
Laatste bezoek van de laatste patient
Vroegtijdige onderbreking van de studie in geval van méér dan 3 stent tromboses in de studie binnen 6 maanden na de index procedure en er geen tekenen zijn van non-adherence. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |