Patient with NSTE-ACS referred for coronary angiography MedDRA version: 19.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Brilique
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Ticagrelor
CAS Number: 274693-27-5
Other descriptive name: TICAGRELOR
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Greek Corporation of Invasive Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Patients (Female and male) = 18 of age 3. Patients with NSTE-ACS undergoing coronary angiography, eligible for 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women with chidlbearing potential (e.g before postmenopausal condition, that is defined as absence of menstruation for 12months, without any other known medial cause) 2. Severe comorbidity (estimated life expectancy 5 ×99th percentile URL. 4. End-stage renal disease(eGFR50 6. Patients with an indication for oral anticoagulation 7. Patients on maintenance therapy with ticagrelor or clopidogrel the last 7 days 8. Use of nicorandil or glibenclamide the last 7 days 9. Concomitant theophylline/aminophylline use the last 7 days 10. Known contraindications to the use of ticagrelor I. Hypersensitivity to the active substance or to any of the excipients II. Active pathological bleeding III. History of intracranial haemorrhage IV. Moderate to severe hepatic impairment V. Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate superior efficacy of a combination of ticagrelor and RIPC in the reduction of PMI compared to a clopidogrel-RIPC combination or ticagrelor alone, by evaluating post-procedural cardiac Troponin I (cTnI) levels, defined as cTnI at 24 hours post-PCI.;Secondary Objective: Evaluation of chest pain during coronary balloon occlusion. Chest pain severity assessed with a numerical 10 point scale (0: no pain, 10: most severe discomfort ever experienced) Evaluation of ECG evidence of ischemia during coronary balloon occlusion. ST-segment deviation as monitored during coronary balloon occlusion.;Primary end point(s): Cardia Troponin Iin 24 hours after PCI;Timepoint(s) of evaluation of this end point: 24 hours after PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Chest pain severity assessed with a numerical 10 point scale (0: no pain, 10: most severe discomfort ever experienced), AND ST-segment deviation as monitored during coronary balloon occlusion ;Timepoint(s) of evaluation of this end point: After PCI procedure | — |
Countries
Greece
Contacts
Public ContactIoannis Tsiafoutis
1st Cardiology Clinic of "Korgialeneio-Benakeio" General Hospital of Athens
Outcome results
None listed