EUCTR2014-000952-26-GBActive, not recruitingPhase 1
Dual Antiplatelet Therapy to Inhibit Coronary Atherosclerosis and Myocardial Injury in Patients with Necrotic High-risk Coronary Plaque Disease - DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury
niversity of Edinburgh0 sites202 target enrollmentStarted: July 4, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 202
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1) Patients aged =40 years with angiographically proven multivessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery).
- •2) Provision of informed consent prior to any study specific procedures
- •3) Receiving aspirin
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
Exclusion Criteria
- •1.An acute coronary syndrome within the last 12 months
- •2.An indication for dual anti-platelet therapy, such as drug eluting stent
- •3.Receiving thienopyridine therapy such as clopidogrel or prasugrel
- •4.Percutaneous coronary intervention or coronary artery bypass graft surgery within the last 3 months
- •5.Inability or unwilling to give informed consent
- •6.Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial
- •7.Known hypersensitivity to ticagrelor or one of its excipients
- •8.Active pathological bleeding or bleeding diathesis
- •9.Significant thrombocytopenia: platelets <100 x 109 /L
- •10. History of intracranial haemorrhage
- •11.Moderate to severe liver impairment (Child’s Grade B or C)
- •12.Maintenance therapy with strong CYP3A4 inhibitors, such as ketoconazole, nefazodone, ritonavir, indinavir, atazanavir, or clarithromycin
- •13.Major intercurrent illness or life expectancy <1 year
- •14.Renal dysfunction (eGFR =30 mL/min/1.73 m2)
- •15.Contraindication to iodinated contrast agents
- •16.Planned coronary revascularization or major non-cardiac surgery in the next 12 months
- •17. Maintenance therapy with simvastatin or lovastatin at doses greater than 40mg daily
- •18.Receiving oral anticoagulants including warfarin, rivaroxaban, dabigatran or apixaban.
Investigators
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