Acute coronary syndrome MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Brilique 90 mg
Product Name: Ticagrelor
Pharmaceutical Form: Tablet
INN or Proposed INN: Ticagrelor
CAS Number: 274693275
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, subjects should fulfil the following criteria: 1. Provision of informed consent prior to any study specific procedures 2. Male or female aged greater than 18 years 3. Previous diagnosis of acute coronary syndrome greater than 30 days and less than 10 months before enrolment 4. Receiving dual antiplatelet therapy with aspirin 75 mg once daily and ticagrelor 90 mg twice daily 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 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1. Presence of an indication for dual antiplatelet therapy other than ischaemic heart disease 2. PCI with drug eluting or bare metal stent(s) within 30 days of randomization 3. Any history of stent implantation to the left main coronary artery 4. Any history of stent thrombosis during dual antiplatelet therapy 5. Planned procedure for coronary revascularization 6. Any planned surgery or other procedure that may require suspension or discontinuation of dual antiplatelet therapy expected to occur within 3 months of randomisation 7. Prior intention by patient or physician to discontinue aspirin and/or ticagrelor within the study period 8. Receiving doses of aspirin and ticagrelor other than 75 mg once daily and 90mg twice daily respectively 9. Treatment or planned treatment with antiplatelet medication apart from aspirin or ticagrelor (eg. clopidogrel, prasugrel, dipyridamole, ticlopidine). 10. Current use of a loop, thiazide or potassium sparing diuretic (affects prostanoid assays). 11. Any acute coronary syndrome event within 30 days prior to randomization. 12. Most recent acute coronary syndrome event greater than 10 months prior to randomization. 13. Current or planned use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban) or parenteral anticoagulant (eg. unfractionated heparin, low molecular weight heparin, bivalirudin). 14. Current or planned use of a GPIIb/IIIa inhibitor (eg. abciximab, tirofiban). 15. Current or planned use of a fibrinolytic agent (eg. tissue plasminogen activator). 16. Requiring or likely to require treatment with a non-steroidal anti-inflammatory drug (NSAID), including COX2 inhibitors, and including regular or intermittent/as required use. 17. Receiving a strong inhibitor of CYP3A4 (eg, ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin [but not erythromycin or azithromycin], nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, or over 1 litre daily of grapefruit juice). 18. Receiving simvastatin or lovastatin at doses higher than 40 mg daily. 19. Receiving a CYP3A substrate with a narrow therapeutic index (e.g. cyclosporine or quinidine). 20. Receiving a strong inducer of CYP3A (e.g. rifampin/rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital). 21. History of acute or chronic liver disease (e.g. cirrhosis). 22. End-stage renal failure requiring dialysis. 23. History of alcohol or drug abuse in the last year. 24. Co-morbidity associated with life expectancy less than 1 year. 25. Any other condition deemed by the investigator to affect haemostasis, coagulation, bleeding risk or ability to comply with the study protocol. 26. Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception (i.e. established use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception with spermicide or sole male partner with prior vasectomy and confirme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The 3 co-primary outcome measures are: 1. Post-dose serum thromboxane B2, compared within-patients between the 2 dosing regimens by a paired t test. 2. Post-dose urinary PGI-M, compared within-patients between the 2 dosing regimens by a paired t test. 3. Ratio of post-dose serum TXB2:urinary PGI-M, compared within-patients between the 2 dosing regimens by a paired t test. ;Main Objective: The principal objective of this study is to assess the effects of two aspirin regimens (very low dose twice daily or standard low dose once daily) on the levels of thromboxane and prostacyclin, substances relevant to platelet activity, measured as their breakdown products in blood and urine, in patients on dual antiplatelet therapy for acute coronary syndromes (heart attacks and severe 'unstable' angina).;Secondary Objective: The secondary objectives of this study are to assess the effect of two different regimens of aspirin on platelet function and on bleeding time; and on variability of effect assessed by serum thromboxane and platelet function. ;Timepoint(s) of evaluation of this end point: At 14 days after commencing study medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Pre-dose serum thromboxane B2. 2. Maximum and final post-dose platelet aggregation induced by 0.1, 0.3 and 1 mM arachidonic acid; 1, 4 and 16 µg/ml collagen; and 20 µM ADP. 3. Maximum and final pre-dose platelet aggregation induced by 0.1, 0.3 and 1 mM arachidonic acid; 1, 4 and 16 µg/ml collagen; and 20 µM ADP. 4. Post-dose bleeding time. 5. Ratio of pre-:post-dose serum TXB2. 6. Ratio of pre-:post-dose maximum and final platelet aggregation induced by 0.1, 0.3 and 1 mM arachidonic acid; 1, 4 and 16 µg/ml collagen; and 20 µM ADP. ;Timepoint(s) of evaluation of this end point: At 14 days after commencing study medication. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Research Office
Sheffield Teaching Hospitals NHS Foundation Trust
Outcome results
None listed