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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

Prasugrel

Ticagrelor

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring ticagrelor, doppler echocardiography

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cardiology Department Patras University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prasugrel

Ticagrelor

Arm Description

Prasugrel 10mg/day for 15 days

Ticagrelor 90mg twice a day for 15 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT01642966

First Posted

July 12, 2012

Last Updated

January 21, 2013

Sponsor

University of Patras

1. Study Identification

Unique Protocol Identification Number

NCT01642966

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Patras

4. Oversight

Data Monitoring Committee

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

ticagrelor, doppler echocardiography

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prasugrel

Arm Type

Active Comparator

Arm Description

Prasugrel 10mg/day for 15 days

Arm Title

Ticagrelor

Arm Type

Experimental

Arm Description

Ticagrelor 90mg twice a day for 15 days

Intervention Type

Drug

Intervention Name(s)

Prasugrel

Intervention Description

Prasugrel 10mg/day for 15 days

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Intervention Description

Ticagrelor 90mg twice a day for 15 days

Primary Outcome Measure Information:

Title

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

Description

The primary outcome will be assessed 15 days after the onset of each study drug

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Time Frame

15 days

Title

Time Frame

15 days

Title

Time Frame

15 days

Title

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Cardiology Department Patras University Hospital

City

Patras

State/Province

Achaia

ZIP/Postal Code

26500

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

23735473

Citation

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.

Results Reference

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

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