Coronary Artery Disease (CAD) MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10072685 Term: Microvascular coronary artery disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 2
Conditions
Interventions
Trade Name: Ticagrelor
Product Name: Ticagrelor
Product Code: [Non Applicabile]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ticagrelor
CAS Number: 274693-27-5
Current Sponsor code: As
Sponsors
Region Skåne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Men or women =18 years of age 3. Diagnosed with T2DM defined as treatment with ongoing glucose lowering drug (oral medications and/or insulin) for at least 1 month 4. Presence of CAD undergoing elective PCI 5. Impaired coronary microvascular function post PCI as defined by a CFR =2.5 6. TIMI 3 flow post PCI Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 114
Exclusion criteria
Exclusion criteria: 1. Previous MI defined as a documented hospitalization with a final diagnosis of spontaneous MI (with the exception of definite secondary MI [e.g., due to coronary revascularization procedure, profound hypotension, hypertensive emergency, tachycardia, or profound anemia]). 2. Previous stroke (transient ischemic attack [TIA] is not included in the stroke definition) 3. Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI 4. On treatment with clopidogrel, prasugrel, or ticagrelor due to a prior acute major CV event (MI or stroke) (on treatment with clopidogrel due to prior vascular intervention not secondary to a major CV event is allowed) 5. Planned use of aspirin treatment at doses >150 mg od 6. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices that cannot be stopped for the course of the study: a. Strong CYP3A4 inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir b. CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily 7. Hypersensitivity to ticagrelor or any of its excipients 8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin 9. Patients with known bleeding diathesis or coagulation disorder 10. History of intracerebral bleed at any time, gastrointestinal (GI) bleed within the past 6 months prior to randomization, or major surgery within 30 days prior to randomization 11. Increased risk of bradycardic events (e.g., known sick sinus syndrome, second or third-degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker 12. Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy) 13. Renal failure requiring dialysis 14. Known platelet count <145 x109 platelets/L 15. Known hemoglobin <9 g/dL 16. Women of child-bearing potential (WOCBP), who are not willing to use a method of contraception that is considered highly reliable per CTFG (Clinical Trial Facilitation Group), OR who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding 17. Inability of the patient to understand and/or comply with study procedures and/or follow up, in the opinion of the investigator, OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study 18. Life expectancy of less than 6 month based on investigator’s judgement 19. Participation in another clinical study with an investigational (defined as nonapproved) product, if taken within five half-lives or 28 days prior to the first administration of the trial medication, whichever is longer 20. Previous randomization in the present study 21. Severe asthma 22. Hypersensitivity to adenosine or mannitol 23. Long QT syndrome 24. Chronic obstructive lung disease, with evidence of bronchospasm 25. Severe low blood pressure 26. Unstable angina pectoris 27. Severe heart failure 28. Hypovolemia 29. Treatment with dipyradimol 30. Increased intracranial pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of Ticagrelor on change from baseline in Coronary Flow Velocity Reserve (CFR) at 30 days.;Secondary Objective: To assess the effect of Ticagrelor on coronary flow parameters at 30 days. To assess the safety and tolerability of Ticagrelor at 30 days.;Primary end point(s): Difference in mean of individual absolute change from baseline to 30 days in Coronary Flow Velocity Reserve (CFR) in the middistal segment of the left anterior descending (LAD) coronary artery under adenosine infusion measured by Transthoracic Doppler Echocardiography (TDE) between the two arms.;Timepoint(s) of evaluation of this end point: The Endpoint for the study is at day 30+/- 3 days after Patient was randomized, got initial CFR measurement and medication was handed over. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in mean of individual absolute change from baseline at 30 days in: - LAD hyperemic mean diastolic flow velocity - LAD resting mean diastolic flow velocity - Bleeding complications (BARC 2, 3 and 5) - Mortality - Myocardial Infarction - Definite and probable stent thrombosis - Serious Adverse Events (SAEs);Timepoint(s) of evaluation of this end point: The Endpoint for the study is at day 30+/- 3 days after Patient was randomized, got initial CFR measurement and medication was handed over. | — |
Countries
Denmark, Germany, Italy, Sweden
Contacts
Public ContactUlf Malmqvist
Region Skåne
Outcome results
None listed