Acute Coronary Syndrome Clinical Trial
Official title:
Differential Effect of Ticagrelor Versus Prasugrel on the Adenosine-induced Coronary Vasodilatory Responses in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.
Verified date | January 2013 |
Source | University of Patras |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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 .
Status | Completed |
Enrollment | 56 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 74 Years |
Eligibility |
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 < ???? 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Cardiology Department Patras University Hospital | Patras | Achaia |
Lead Sponsor | Collaborator |
---|---|
University of Patras |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The primary outcome will be assessed 15 days after the onset of each study drug | 15 days | No |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No |
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