Status
Enrolling
Condition
Peripheral Artery Disease (PAD)
Description
A randomized, double-blind, parallel group, Multicenter study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischaemic stroke in patients with established PAD
1. Male and female patients ≥ 50 years of age
2. Symptomatic lower extremity PAD defined by:
Symptoms at the time of screening including classic claudication, other exertional leg discomfort associated with physical limitations from PAD, ischaemic rest pain, ischaemic ulcers, or gangrene AND
Ankle brachial index (ABI) measurement of ≤ 0.80 at Visit 1. The ABI must
be ≤ 0.85 at Visit 2. If ABI is ≥ 1.40 then the toe brachial index (TBI) must
be ≤ 0.60 at Visit 1 and the TBI must be ≤ 0.65 at Visit 2.
OR
Prior lower extremity revascularization for symptomatic and haemodynamically significant PAD greater than 30 days prior to randomization, irrespective of present leg symptoms and the ABI or TBI at the time of study screening.
3. Written informed consent prior to any study specific procedures.
1. Male and female patients ≥ 50 years of age
2. Symptomatic lower extremity PAD defined by:
Symptoms at the time of screening including classic claudication, other exertional leg discomfort associated with physical limitations from PAD, ischaemic rest pain, ischaemic ulcers, or gangrene AND
Ankle brachial index (ABI) measurement of ≤ 0.80 at Visit 1. The ABI must
be ≤ 0.85 at Visit 2. If ABI is ≥ 1.40 then the toe brachial index (TBI) must
be ≤ 0.60 at Visit 1 and the TBI must be ≤ 0.65 at Visit 2.
OR
Prior lower extremity revascularization for symptomatic and haemodynamically significant PAD greater than 30 days prior to randomization, irrespective of present leg symptoms and the ABI or TBI at the time of study screening.
3. Written informed consent prior to any study specific procedures.
Purpose
This study is being carried out to see if a new medication called ticagrelor given twice daily is effective in preventing the occurrence of heart attack, stroke and/or death due to heart problems in patients who have peripheral arterial disease and if so, how it compares with clopidogrel, given once daily.
Phase
3b
Key Inclusion Criteria
1. Male and female patients ≥ 50 years of age
2. Symptomatic lower extremity PAD defined by:
Symptoms at the time of screening including classic claudication, other exertional leg discomfort associated with physical limitations from PAD, ischaemic rest pain, ischaemic ulcers, or gangrene AND
Ankle brachial index (ABI) measurement of ≤ 0.80 at Visit 1. The ABI must
be ≤ 0.85 at Visit 2. If ABI is ≥ 1.40 then the toe brachial index (TBI) must
be ≤ 0.60 at Visit 1 and the TBI must be ≤ 0.65 at Visit 2.
OR
Prior lower extremity revascularization for symptomatic and haemodynamically significant PAD greater than 30 days prior to randomization, irrespective of present leg symptoms and the ABI or TBI at the time of study screening.
3. Written informed consent prior to any study specific procedures.
Key Exclusion Criteria
1. Hypersensitivity to clopidogrel or ticagrelor
2. Patients requiring dual anti-platelet therapy at study entry
3. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin or long-term treatment with fondaparinux
4. Planned (and judged necessary) use of ticlopidine, prasugrel, aspirin or
dipyridamole
5. Planned (and judged necessary) use of omeprazole or esomeprazole. Note – the use of other proton pump inhibitors is permitted.
6. Concern for inability of the patient to comply with study procedures and/or follow-up (eg, alcohol or drug abuse)
7. Any condition which in the opinion of the Investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer, use of strong or moderate CYP2C19 inhibitors, long-term concomitant treatment with non-steroidal anti-inflammatory drugs [NSAIDs])
ClinicalTrials.gov Identifier
Not available at this time
