E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
(Chronic) Peripheral (occlusive) arterial disease (PAD) |
(Chronisch) Perifeer arterieel vaatlijden (PAV) |
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E.1.1.1 | Medical condition in easily understood language |
Narrowed/blockage of arteries in the lower extremities |
verstopping in de slagaders van de benen |
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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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to assess whether and to what extent dual therapy clopidogrel/aspirin (80 mg) is superior to clopidogrel (75mg daily) alone, in reducing cardiovascular adverse events after one-year follow-up in PAD patients who underwent endovascular treatment. |
Het primaire doel is om te beoordelen in hoeverre duale therapie (clopidogrel/aspirine) superieur is aan clopidogrel monotherapie wat betreft het verminderen van cardiovasculaire bijwerkingen na één jaar bij patiënten met perifeer arterieel vaatlijden die een endovasculaire behandeling hebben ondergaan. |
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E.2.2 | Secondary objectives of the trial |
It is also determined if non-responsiveness to clopidogrel predicts outcome. CYP2C19 polymorphisms will be determined at the end of the trial. The findings will not change clinical practice within the course of the trial. |
- In hoeverre duale therapie het optreden van ernstige bloedingen verhoogd t.o.v. monotherapie. - In hoeverre duale therapie het optreden van bijwerkingen aan de ledematen en cardiovasculaire aandoeningen vermindert bij patiënten met perifeer arterieel vaatlijden die binnen 30 dagen een endovasculaire behandeling ondergingen - Niet reactiviteit op clopidogrel: Genotypering van CYP2C19 in bloedmonsters. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Lesions of the iliac, femoropopliteal and/or below-the-knee (BTK) arteries - Eligibility of lesions for percutaneous transluminal angioplasty (PTA) or recanalization with or without additional stenting based on prevailing guidelines - Hybrid procedure with an endarterectomy of the common femoral artery and additional iliac, femoral or tibial PTA - All TASC lesions - Rutherford (3-6) classes - Proficient understanding of the consequences of enrolment - Age ≥18 years |
Alle PAV patiënten met een indicatie voor een endovasculaire behandeling (iliacaal, femoraal en cruraal) Alle soorten TASC laesies Rutherford (3-6) Leeftijd ≥18 jaar
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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: - Acute (limb) ischemia - Reported intolerance or hypersensitivity for the study medications - Use of anticoagulant therapy (DOACs and coumarin) - Use of non-steroidal anti-inflammatory drugs >2 weeks - A history of platelet/bleeding abnormalities - Patient with malignancy and therefore a life expectancy less than one year - Patients incompetent of understanding the consequences of enrolment in the trial. - Patients with a previous intervention in the target lesion within 3 months - Patients with a hybrid procedure such as femoral bypass and an iliac or tibial PTA |
Acute (limb) ischemie Intolerantie voor studie medicatie Gebruik van anticoagulantia (DOACs and coumarin) Patienten met een maligniteit en hierdoor levensverwachting van minder dan 1 jaar Patiënten die niet in staat zijn de gevolgen van deelname aan de studie te begrijpen
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the occurrence of cardiovascular adverse events after one year: re-intervention due to any restenosis or re-occlusion of the target lesion or acute limb ischemia, the occurrence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death. |
Het primaire eindpunt is het optreden van cardiovasculaire bijwerkingen na één jaar: re-interventie als gevolg van enige restenose of re occlusie van de laesie, acute ischemie van de de onderste extremiteiten, amputatie, cerebrovasculaire incidenten, myocardinfarct, overlijden t.g.v. cardiovasculaire problematiek. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After one year |
Na één jaar |
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E.5.2 | Secondary end point(s) |
Secondary endpoint is the occurrence of major and minor bleeding. According to the Thrombolysis In Myocardial Infarction (TIMI) criteria or Bleeding Academic Research Consortium (BARC) criteria |
Het secundaire eindpunt is het optreden van grote en kleine bloedingen. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After one year. |
Na één jaar |
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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 | No |
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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 848 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
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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One year after the inclusion of last patient. |
Eén jaar na de inclusie van de laatste patiënt. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |