To compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischaemic stroke in patients with established peripheral artery disease.
ID
Source
Brief title
Condition
- Other condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
cardiovasculair overlijden, hartaanval en beroerte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time from randomisation to first occurrence of any event in the composite of CV
death, MI, and ischaemic stroke.
Secondary outcome
1. Composite of CV death and MI, Ischaemic Stroke and Acute Limb Ischemia (ALI)
requiring hospitalization.
2. CV death.
3. MI.
4. all cause mortality.
5. Composite of CV death and MI, all-cause Stroke (ischaemic or haemorrhagic)
6. Acute Limb Ischemia (ALI) requiring hospitalization
7. All lower Revascularization
8. All revascularization procedures.
Background summary
Atherosclerosis with associated arterial thrombosis is a systemic disease that
can affect the cardiovascular, cerebrovascular and the peripheral vascular
systems. Atherosclerosis of the arteries supplying the limbs is referred to as
Peripheral artery disease (PAD).
Patients with PAD have a significant systemic atherosclerotic disease burden.
Clinical manifestations associated with lower extremity PAD include decrements
in functional capacity and quality of life, including loss of limb. Patients
with PAD also have elevated levels of platelet activity and are at substantial
increased risk for platelet mediated adverse events, such as myocardial
infarction (MI), ischaemic stroke, and cardiovascular (CV) death.
In the CAPRIE study, clopidogrel, an irreversible adenosine diphosphate (ADP)
receptor antagonist, has shown particular benefit in a PAD population, when
compared with ASA alone.
Ticagrelor (AZD6140) is a reversibly-binding, potent, oral adenosine
diphosphate P2Y12 receptor blocker. In the PLATO study, ticagrelor was shown to
be superior to clopidogrel in an ACS population, when given in addition to
aspirin (ASA). Since established lower extremity PAD is closely associated
with atherosclerosis with vulnerable plaques and intravascular macro-and
microthrombosis in other vascular territories, it is likely that more complete
platelet inhibition may prevent additional atherothrombotic events in this
population.
The current study is being conducted to determine whether treatment with
ticagrelor, given as antiplatelet monotherapy, will reduce the incidence of
atherothrombotic ischaemic events compared to treatment with clopidogrel
monotherapy as measured by the composite of CV death MI, and ischaemic stroke
in a population with established PAD.
Study objective
To compare ticagrelor with clopidogrel treatment on the risk of cardiovascular
death, myocardial infarction and ischaemic stroke in patients with established
peripheral artery disease.
Study design
Randomised, double blind, parallel group, multicentre phase IIIb study.
Intervention
Patients will receive ticagrelor 90 mg orally bd/ placebo or clopidogrel 75 mg
orally ob/ placebo for a minimum treatment period of 18 months.
Study burden and risks
The patient is asked to visit the site at least 8 times and maximum 11 times.
The total time will last 8-11 hour.
Blood samples will be taken in this study. The total volume of blood that will
be collected is approximately 23 ml.
The patient will be asked to fill out a short questionnaire on his/ her quality
of life and condition at maximum 5 visits.
The patient will undergo one physical examination and will have one
electrocardiogram.
Woman of child-bearing potential have to provide a urine sample to test for
pregnancy.
The patient will be asked to undergo an ABI measurement for a maximum of 9
times.
The study medication may cause some side effects. The taking of blood sample
may cause some discomfort and there is the possibility of bruising.
Louis Pasteurlaan 5
2719 EE Zoetermeer 2719EE
NL
Louis Pasteurlaan 5
2719 EE Zoetermeer 2719EE
NL
Listed location countries
Age
Inclusion criteria
1. Male and Female patients 50 years old or older
2. Symptomatic peripheral artery disease;For other inclusion criteria see protocol page 31.
Exclusion criteria
1. Patients needing dual anti-platelet drug treatment before start of study
2. Planned revascularisation or amputation
3. Patients with known bleeding disorders
4. Patients with a history of intracranial bleed
5. Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker;For other exclusion criteria see protocol page 31-33.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-004616-36-NL |
| CCMO | NL41301.058.12 |