Effect of Ticagrelor on Fractional Flow Reserve

NCT ID: NCT02108808

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-10-31

Brief Summary

Fractional flow reserve (FFR) is an established invasive method for assessing the physiological significance of coronary artery stenosis. Adenosine, an important endogenous regulator of coronary blood flow during both stress and ischemia, is widely used to achieve conditions of stable hyperemia required for measurement of FFR.

Studies in healthy volunteers and in patients with acute coronary syndrome (ACS) post percutaneous coronary intervention (PCI) receiving ticagrelor revealed a differential coronary blood flow velocity response during increasing doses of adenosine compared to placebo or prasugrel treated subjects, respectively. It has also been demonstrated that patients treated with ticagrelor have increased plasma adenosine levels. Therefore, it has been hypothesized that the degree of hyperemia obtained with adenosine infusion may be greater in patients on ticagrelor than that obtained in patients taking clopidogrel or prasugrel. If this proves to be true, it would lead to a lower FFR value with possible important clinical implications in ticagrelor receiving patients in need for FFR measurement.

This is a prospective, single center, randomized study of parallel design. Consecutive ticagrelor naive patients who are referred for coronary angiography and have an angiographically moderate to severe de novo stenosis (>50% and <90% diameter by visual assessment) in at least one major epicardial coronary artery amenable to PCI are candidates for this study. Patients after informed consent will be randomized (hour 0) to receive immediately post FFR (with adenosine iintravenous infusion at 140 μg/Kg/min for a 3 minute period) either ticagrelor 180mg loading dose or prasugrel 60mg/clopidogrel 600mg loading dose (as clinically indicated). FFR examination will be repeated 2 hours post loading dose.

Conditions

Fractional Flow Reserve

Study Design

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

Study Groups

Prasugrel or Clopidogrel

Prasugrel 60mg or Clopidogrel 600mg loading dose, as clinically indicated

Group Type: ACTIVE_COMPARATOR

Prasugrel or Clopidogrel

Intervention Type: DRUG

Ticagrelor

Ticagrelor 180mg loading dose

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

Interventions

Ticagrelor

Intervention Type: DRUG

Prasugrel or Clopidogrel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years

2. Patients subjected to clinically indicated coronary angiography with at least one 50%-90% stenosis at 1 major epicardial vessel (by visual assessment) amenable to percutaneous coronary intervention.

3. Ticagrelor naive patients

4. Written informed consent

Exclusion Criteria

1. History of coronary artery bypass surgery

2. Acute myocardial infarction within the previous 5 days

3. Known allergy to adenosine, ticagrelor, prasugrel or clopidogrel

4. Prior intracranial hemorrhage

5. Hemodialysis or creatinine clearance < 30ml/h

6. Moderate/severe hepatic failure

7. Active bleeding, or at increased risk of bleeding

8. Left ventricular ejection fraction <40%

9. Primary myocardial or valvular disease

10. Contraindication to adenosine

11. Angiographically visible thrombus at a target lesion, extremely tortuous coronary arteries, severely calcified lesions, left main disease, anatomy suitable for coronary artery bypass surgery

12. Previous q wave myocardial infarction in the area of target vessel

13. Severe left ventricular hypertrophy

14. Severe valvular heart disease

15. Heart failure as defined by New York Heart Association class III or IV 16.Hypotension (blood pressure <90 mm Hg)

17.Significant arrhythmia (e.g. excessive premature ventricular contractions or atrial fibrillation), tachycardia (heart rate >120 beats/min), bradycardia (<50 beats/min), increased risk for bradycardia 18.Caffeine consumption or cigarette smoking within the previous 24 hours.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Alexopoulos

Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Patras University Hospital

Pátrai, Achaia, Greece

Countries

Greece

Other Identifiers

PATRAS CARDIOLOGY 18

Identifier Type: -

Identifier Source: org_study_id