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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28759
Enrollment
1252
Registered
2015-11-04
Start date
2016-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antiplatelet therapy, peripheral transluminal angioplasty

Interventions

Intervention is comparing dualtherapy aspirin (80mg)/clopidogrel (75mg) to ticagrelor (90mg) and the current practice aspirin 80mg.

Sponsors

Antonius Hospital Nieuwegein, Medisch Centrum Alkmaar.
Lead Sponsor

Eligibility

Inclusion criteria

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: 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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary endpoint is occurrence of major and minor bleeding. According the TIMI criteria.

Contacts

Public ContactC. Unlu

Medisch Centrum Alkmaar

c.unlu@mca.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)