Our hypothesis is that both dual therapy with aspirin and clopidogrel or ticagrelor alone will lead to a lower occurrence of atherothrombotic events in patients following endovascular intervention compared to aspirin. We also hypothesize that the…
ID
Bron
Verkorte titel
Aandoening
antiplatelet therapy, peripheral transluminal angioplasty
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint is the occurrence of the cardiovascular events myocardial infarction, in-stent thrombosis, re-intervention due to hemodynamic re-stenosis, the occurrence of cerebrovascular event (CVA or/and TIA), peripheral embolus and mortality after one year of follow-up.
Doel van het onderzoek
Our hypothesis is that both dual therapy with aspirin and clopidogrel or ticagrelor alone will lead to a lower occurrence of atherothrombotic events in patients following endovascular intervention compared to aspirin. We also hypothesize that the bleeding risk of ticagrelor will be non-inferior compared to clopidogrel and aspirin.
Onderzoeksopzet
Patients will receive regular follow-up, at 12 months, including duplex ultrasound at 12 months. All data will be prospectively collected and entered into a central database. Clinical follow-up will be obtained by contacting all patients at 12 months, and a double check will be performed on the basis of source documents obtained from medical records. In case of death the general practitioner will be asked for the possible reason for death
Onderzoeksproduct en/of interventie
Intervention is comparing dualtherapy aspirin (80mg)/clopidogrel (75mg) to ticagrelor (90mg) and the current practice aspirin 80mg.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All patients presented for percutaneous endovascular intervention are eligable for inclusion. Inclusion criteria: (1) lesions to the iliac, femoropopliteal and below the knee (BTK) arteries; (2) eligibility of lesions for percutaneous transluminal angioplasty (PTA) or recanalization with or without additional stenting (ST), (3) all TASC lesions [16]; (4) all Rutherford (1-6) classes.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion criteria are patients with reported intolerance or hypersensitivity for the study medications, the use of anticoagulant therapy (coumarin derivatives; acenocoumarol / fenprocoumon / warfarin), the use of non-steroidal anti-inflammatory drugs in the two weeks prior to the venapuncture to determine eventual aspirin resistance, a history of platelet/bleeding abnormalities and a platelet count < 100x*10^6/dl.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5538 |
| NTR-old | NTR5658 |
| Ander register | : 56795 |