Differential Effect of Ticagrelor Versus Prasugrel on the Adenosine-induced Coronary Vasodilatory Responses in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

NCT ID: NCT01642966

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-09-30

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 .

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prasugrel

Prasugrel 10mg/day for 15 days

Group Type: ACTIVE_COMPARATOR

Prasugrel

Intervention Type: DRUG

Prasugrel 10mg/day for 15 days

Ticagrelor

Ticagrelor 90mg twice a day for 15 days

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

Ticagrelor 90mg twice a day for 15 days

Interventions

Prasugrel

Prasugrel 10mg/day for 15 days

Intervention Type: DRUG

Ticagrelor

Ticagrelor 90mg twice a day for 15 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Alexopoulos

Professor of Cardiology, Director of Cardiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cardiology Department Patras University Hospital

Pátrai, Achaia, Greece

Countries

Greece

References

Alexopoulos D, Moulias A, Koutsogiannis N, Xanthopoulou I, Kakkavas A, Mavronasiou E, Davlouros P, Hahalis G. Differential effect of ticagrelor versus prasugrel on coronary blood flow velocity in patients with non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention: an exploratory study. Circ Cardiovasc Interv. 2013 Jun;6(3):277-83. doi: 10.1161/CIRCINTERVENTIONS.113.000293. Epub 2013 Jun 4.

Reference Type: DERIVED

PMID: 23735473 (View on PubMed)

Other Identifiers

PATRASCARDIOLOGY-12

Identifier Type: -

Identifier Source: org_study_id