Acute Coronary Syndrome
Conditions
Keywords
ticagrelor, doppler echocardiography
Brief summary
This is a prospective, randomized, single-blind, investigator-initiated, crossover study. Patients with Acute Coronary Syndrome (ACS) subjected to percutaneous coronary intervention (PCI), are randomized after informed consent, in a 1:1 ratio to either ticagrelor 90mg x2 or prasugrel 10mg x1 for 15 days. At Day 15± 2 days, coronary diastolic blood flow velocity in left anterior descending artery (LAD) is evaluated at baseline (bCBFV) and under 2 min adenosine infusions (maximal diastolic CBFV- maxCBFV) at gradually increasing doses of 50μg/kg/min, 80μg/kg/min, 110μg/kg/min and 140μg/kg/min with at least 5 min recovery intervals between infusions. A crossover directly to the alternate treatment is performed followed by the same evaluation at Day 30±2 days .
Interventions
DRUGPrasugrel
Prasugrel 10mg/day for 15 days
DRUGTicagrelor
Ticagrelor 90mg twice a day for 15 days
Sponsors
University of Patras
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-74 years * Patients with acute coronary syndrome undergoing PCI with stenting * Sinus rhythm * Written informed consent
Exclusion criteria
* Known hypersensitivity to prasugrel or ticagrelor * Requirement for oral anticoagulant prior to the Day 30 visit * Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm) * Any active bleeding or history of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months, other bleeding diathesis, or considered by investigator to be at high risk for bleeding * Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine). * Increased risk of bradycardiac events. * Dialysis required. * Severe uncontrolled chronic obstructive pulmonary disease * Known severe hepatic impairment * Pregnancy or breastfeeding * Left ventricular ejection fraction \< 45%, severe left ventricular hypertrophy, diastolic dysfunction, severe valve disease * Prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting * Weight \< 60 Kg * Alcohol or narcotics abuse * Major periprocedural complications: death, cardiogenic shock, stent thrombosis, arrhythmias requiring cardioversion/defibrillation, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, retroperitoneal bleeding, major bleeding (need for blood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding), unsuccessful PCI (residual stenosis \> 30% or flow \< ΤΙΜΙ 3) or planned staged PCI in the next 5 days after randomization * Any residual stenosis \> 40% in LAD * Small vessels or diffuse coronary atherosclerosis * Inability to detect coronary blood flow in LAD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The area under the curve (AUC) of the maxCBFV (maximal diastolic blood flow velocity in left anterior descending artery)at gradually increasing doses of adenosine | 15 days | The primary outcome will be assessed 15 days after the onset of each study drug |
Secondary
| Measure | Time frame |
|---|---|
| The ratio of maximal diastolic blood flow velocity in left anterior descending artery/baseline diastolic blood flow velocity in left anterior descending artery for 50μg/kg/min adenosine infusion at the end of treatment periods | 15 days |
| The ratio of maximal diastolic blood flow velocity in left anterior descending artery/baseline diastolic blood flow velocity in left anterior descending artery for 80μg/kg/min adenosine infusion at the end of treatment periods | 15 days |
| The ratio of maximal diastolic blood flow velocity in left anterior descending artery/baseline diastolic blood flow velocity in left anterior descending artery for 110μg/kg/min adenosine infusion at the end of treatment periods | 15 days |
| The ratio of maximal diastolic blood flow velocity in left anterior descending artery/baseline diastolic blood flow velocity in left anterior descending artery for 140μg/kg/min adenosine infusion at the end of treatment periods | 15 days |
Countries
Greece
Outcome results
None listed