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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642966
• Other study ID #: PATRASCARDIOLOGY-12
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2012
• Last updated: January 21, 2013
• Start date: September 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Prasugrel
Prasugrel 10mg/day for 15 days
• Ticagrelor
Ticagrelor 90mg twice a day for 15 days

Locations

Country	Name	City	State
Greece	Cardiology Department Patras University Hospital	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

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