DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury

NCT02110303 | Completed Phase 2

• 1 other identifier: DIAMOND-14/SS/0089
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Heart attacks are most commonly caused by rupture of fatty deposits (plaques) within the wall of heart blood vessels. It appears that this process can also frequently occur without causing any symptoms and these events likely explain the development of narrowing within the heart arteries which can subsequently produce symptoms of angina (chest pain). Previous research has shown a specialised scanner known as a PET (positron emission tomography) scan can identify these recently ruptured plaques in patients without symptoms of a heart attack and these patients have changes on a blood test (troponin) which suggest that they are at higher risk of having a heart attack in the future. This study aims to identify these patients using the PET scan and then see if the markers of increased heart attack risk can be reduced by the use of a blood thinning medication (ticagrelor) which is already a well recognised treatment for people who have suffered a recent heart attack.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Plasma high sensitivity cardiac troponin I (hsTnI) concentration in patients with coronary 18F-fluoride uptake.

  30 days

Secondary Outcomes (4)

• Plasma hsTnI concentrations in patients without coronary 18F-fluoride uptake.

  30 days

• High sensitivity cardiac troponin I (hsTnI) concentration in total study population.

  30 days

• Plasma high-sensitivity troponin (hsTnI) concentration

  1 year

• Calcium score and plaque volume at the site of baseline coronary 18F-fluoride uptake

  1 year

Study Arms (4)

18F-F Positive - Ticagrelor

EXPERIMENTAL

Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration

Drug: Ticagrelor

18F-F Positive - Placebo

PLACEBO COMPARATOR

Identical placebo, one tablet, twice daily, 12 month duration

Drug: Placebo

18F-F Negative - Ticagrelor

EXPERIMENTAL

Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration

Drug: Ticagrelor

18F-F Negative - Placebo

PLACEBO COMPARATOR

Identical placebo, one tablet, twice daily, 12 month duration

Drug: Placebo

Interventions

Ticagrelor DRUG

oral, 90mg tablets, twice daily, 12 month duration

Also known as: Brilique, Brilinta, Possia, AZD6140, SUB30898, B01AC24

18F-F Negative - Ticagrelor; 18F-F Positive - Ticagrelor

Placebo DRUG

Oral tablet (identical to ticagrelor), twice daily, 12 month duration

18F-F Negative - Placebo; 18F-F Positive - Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Provision of informed consent prior to any study specific procedures

You may not qualify if:

• An acute coronary syndrome within the last 12 months
• An indication for dual anti-platelet therapy, such as drug eluting stent
• Inability to take aspirin
• Receiving thienopyridine therapy such as clopidogrel or prasugrel
• Percutaneous coronary intervention or coronary artery bypass graft surgery within the last 3 months
• Inability or unwilling to give informed consent
• Woman with child-bearing potential and who are breastfeeding will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant)
• Known hypersensitivity to ticagrelor or one of its excipients
• Active pathological bleeding or bleeding diathesis
• Significant thrombocytopenia: \<100 x 10\^9 /L
• History of intracranial haemorrhage
• Moderate to severe liver impairment (Child's Grade B or C)
• Maintenance therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors, such as ketoconazole, nefazodone, ritonavir, indinavir, atazanavir, or clarithromycin
• Major intercurrent illness or life expectancy \<1 year
• Renal dysfunction (eGFR ≤30 mL/min/1.73 m2)

Sponsors & Collaborators

• University of Edinburgh: lead
• AstraZeneca: collaborator

Study Sites (1)

Edinburgh Heart Centre

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Related Publications (6)

• Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.

  PMID: 24224999 BACKGROUND

• Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037.

  PMID: 22516444 BACKGROUND

• Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

  PMID: 19717846 BACKGROUND

• Doris MK, Meah MN, Moss AJ, Andrews JPM, Bing R, Gillen R, Weir N, Syed M, Daghem M, Shah A, Williams MC, van Beek EJR, Forsyth L, Dey D, Slomka PJ, Dweck MR, Newby DE, Adamson PD. Coronary 18F-Fluoride Uptake and Progression of Coronary Artery Calcification. Circ Cardiovasc Imaging. 2020 Dec;13(12):e011438. doi: 10.1161/CIRCIMAGING.120.011438. Epub 2020 Dec 10.

  PMID: 33297761 DERIVED

• Moss AJ, Dweck MR, Doris MK, Andrews JPM, Bing R, Forsythe RO, Cartlidge TR, Pawade TA, Daghem M, Raftis JB, Williams MC, van Beek EJR, Forsyth L, Lewis SC, Lee RJ, Shah ASV, Mills NL, Newby DE, Adamson PD. Ticagrelor to Reduce Myocardial Injury in Patients With High-Risk Coronary Artery Plaque. JACC Cardiovasc Imaging. 2020 Jul;13(7):1549-1560. doi: 10.1016/j.jcmg.2019.05.023. Epub 2019 Aug 14.

  PMID: 31422134 DERIVED

• Moss AJ, Doris MK, Andrews JPM, Bing R, Daghem M, van Beek EJR, Forsyth L, Shah ASV, Williams MC, Sellers S, Leipsic J, Dweck MR, Parker RA, Newby DE, Adamson PD. Molecular Coronary Plaque Imaging Using 18F-Fluoride. Circ Cardiovasc Imaging. 2019 Aug;12(8):e008574. doi: 10.1161/CIRCIMAGING.118.008574. Epub 2019 Aug 6.

  PMID: 31382765 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• David E. Newby, PhD

  University of Edinburgh

  STUDY CHAIR

• Philip D. Adamson, MBChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2015
• Primary Completion: May 26, 2017
• Study Completion: April 1, 2018
• Last Updated: November 18, 2025

Record last verified: 2019-05

Locations

GB (1)