No registrations found.
ID
Source
Brief title
Health condition
antiplatelet therapy, peripheral transluminal angioplasty
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Secondary endpoint is occurrence of major and minor bleeding. According the TIMI criteria.
Study objective
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.
Study design
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
Intervention
Intervention is comparing dualtherapy aspirin (80mg)/clopidogrel (75mg) to ticagrelor (90mg) and the current practice aspirin 80mg.
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5538 |
| NTR-old | NTR5658 |
| Other | : 56795 |