patients with stable ischemic heart disease with elevation of troponin MedDRA version: 20.0 Level: LLT Classification code 10055218 Term: Ischemic heart disease System Organ Class: 100000004849
Conditions
Interventions
Trade Name: BRILIQUE - 90 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/PVDC/ALU) 60 COMPRESSE
Product Name: Ticagrelor
Product Code: B01AC24
Pharmaceutical Form: Film-coated tablet
INN
Sponsors
AZIENDA UNITÀ SANITARIA LOCALE DELLA ROMAGNA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female and male aged >18 years 3. Stable exertional angina (Class I or II according to the Canadian Cardiovascular Society classification) without significant variation in the preceding 2 months, associated with objective evidence of myocardial ischemia consisting of ischemia on a stress imaging test with nuclear myocardial perfusion, echo or cardiac magnetic resonance wall motion, or cardiac magnetic resonance perfusion or with the finding of significant coronary obstructions (>50% reduction of luminal diameter of a major epicardial vessel) on coronary computed tomography angiography (CCTA) or, 4. At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion (=10% myocardium), echo or cardiac magnetic resonance wall motion (=3/16 segments with stress-induced severe hypokinesis or akinesis), or cardiac magnetic resonance perfusion (=12% myocardium), or the finding of severe coronary obstructions (>70% reduction of luminal diameter of a major epicardial vessel on CCTA) in patients without symptoms attributable to myocardial ischemia or, 5. Spontaneous myocardial infarction 1 to 3 years before enrollment, and one of the following additional high-risk features: age =65 years, diabetes mellitus requiring medication, a second prior spontaneous myocardial infarction, multivessel coronary artery disease, or chronic renal dysfunction, defined as an estimated creatinine clearance of less than 60 ml per minute. 6. Biochemical evidence of myocardial injury (hsTnT= 14 ng/L in male, =10 ng/L in females). 7. Absence of contra-indications to ticagrelor . 8. Participant is willing to comply with all aspects of the protocol, including adherence to medical therapy and follow-up visits. 9. Treatment with ASA at a dose of 75 to 150 mg daily is mandatory in all patients 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1- Age >75 years. 2- Clinical heart failure. 2- LV ejection fraction <50% or regional wall motion abnormalities at echocardiography. 3- Severe chronic kidney disease (glomerular filtration rate < 30 ml/min/1.73 m2 measured with the Modification of Diet in Renal Disease (MDRD) Study Equation). 4- Unacceptable level of angina despite maximal medical therapy. 5- Very dissatisfied with medical management of angina. 6- History of noncompliance with medical therapy. 7- Acute coronary syndrome within the previous 6 months. 8- Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within the previous 12 months. 9- Stroke within the previous 6 months or intracranial hemorrhage at any time. 10- History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia. 11- Planned major surgery necessitating interruption of dual antiplatelet therapy. 12- Need for oral anticoagulation therapy or dual antiplatelet therapy. 13- An increased risk of bradycardia. 14- Concomitant therapy with a strong cytochrome P-450 3A4 inhibitor or inducer. 14- Pregnancy. 15- Inability to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The reduction of the mean levels of hsTnT concentrations at the end of the study period in patient treated with Ticagrelor.;Secondary Objective: - The reduction of the percentage of patients treated with Ticagrelor with hsTnT elevations - The reduction of the percentage of patients treated with Ticagrelor with hsTnI elevations - The reduction of the mean levels of hsTnI concentrations at the end of the study period. ;Primary end point(s): It is expected that the mean hsTnT concentration at baseline will be 30 +/- 15 ng/L and that it will decrease to 15 +/- 10 ng/L at the end of the study. This 50% reduction in Tn levels is based on the biological variability of the hsTn assay in stable CAD patients and can be considered clinically meaningful given the long-term biological variability of hsTnT levels as assessed by the reference change value which is 32% for the hsTnT Roche assay as assessed in patients with stable CAD;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The reduction of the percentage of patients with hsTnT elevations from 100% at baseline to 50% at the end of the study period. -The reduction of the percentage of patients with hsTnI elevations from 100% at baseline to 50% at the end of the study period. - The reduction of the mean levels of hsTnI concentrations at the end of the study period. It is expected that the mean hsTnI concentration at baseline will be 70 +/- 30 ng/L and that it will decrease to 40 +/- 30 ng/L at the end of the study. This 45% reduction can be considered clinically meaningful given the biological variability of Abbott hsTnI levels, as assessed by the reference change value, which is 49% at long term in patients with stable ischemic heart disease ;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Italy
Contacts
Public ContactU.O CARDIOLOGIA FORLI
AUSL ROMAGNA
Outcome results
None listed