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van CCT (UK)


A randomized trial of the effect of antiplatelet therapy (Aspirin, Aspirin and Clopidogrel or Ticagrelor) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty.


- candidate number23358
- NTR NumberNTR5658
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-nov-2015
- Secondary IDs56795 
- Public TitleA randomized trial of the effect of antiplatelet therapy (Aspirin, Aspirin and Clopidogrel or Ticagrelor) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty.
- Scientific TitleA randomized trial of the effect of antiplatelet therapy (Aspirin, Aspirin and Clopidogrel or Ticagrelor) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty.
- ACRONYMASCOT
- hypothesisOur 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.
- Healt Condition(s) or Problem(s) studiedAntitrombotics
- Inclusion criteriaAll 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 criteriaExclusion 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2016
- planned closingdate1-sep-2018
- Target number of participants1252
- InterventionsIntervention is comparing dualtherapy aspirin (80mg)/clopidogrel (75mg) to ticagrelor (90mg) and the current practice aspirin 80mg.
- Primary outcomePrimary 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 outcomeSecondary endpoint is occurrence of major and minor bleeding. According the TIMI criteria.
- TimepointsPatients 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
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD, FEVBS C. Unlu
- CONTACT for SCIENTIFIC QUERIESMD, PhD, FEVBS C. Unlu
- Sponsor/Initiator St. Antonius Hospital, Medisch Centrum Alkmaar
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD4-nov-2015 - 20-mrt-2016


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