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. - ASCOT trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47750

Enrollment

1806

Registered

2019-08-29

Start date

2020-02-24

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

claudicatio peripheral arterial disease

Interventions

Intervention is comparing three groups: dual therapy aspirin (80mg)/clopidogrel (75mg) to ticagrelor (90mg) and the current practice

aspirin 80mg alone

antiplatelet therapy

endovascular intervention

peripheral arterial disease

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All patients of 18 and over with: (1) lesions to the iliac, femoropopliteal or 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 acute ischemia, PAD due to aneurysm abdominal or popliteal, patients with reported intolerance or hypersensitivity for the study medications, impossibility of discontinuing current antiplatelet therapy, 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 venepuncture to determine eventual aspirin resistance, a history of platelet/bleeding abnormalities, a platelet count

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the occurrence of cardiovascular adverse events: thrombo-embolic events, re-stenosis and occlusion, re-intervention due to symptomatic restenosis or re-occlusion, the occurrence of cerebrovascular events, myocardial infarction, and mortality after one year of follow-up.	—

Secondary

Measure	Time frame
Secondary endpoint is occurrence of major and/or minor bleeding. Also it is determined if CYP2C19 polymorphisms and non-responsiveness to aspirin or clopidogrel predicts outcome. The results of these tests are blinded for physicians.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)