DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury

Phase 1

• Conditions: Stable coronary artery disease.; MedDRA version: 17.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-000952-26-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-04
• Study Completion: 2018-04-03
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 202

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified