D

Phase 1

• Conditions: Patients with multivessel coronary artery disease requiring staged, ischemia-guided PCI; MedDRA version: 20.0Level: LLTClassification code 10074572Term: Multiple vessel coronary artery diseaseSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004746-28-IT
• Lead Sponsor: IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-14
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Signed and dated Informed Consent obtained prior to the inclusion in the trial
2.Age > 18 and < 75 years (both inclusive)
3.Weight > 60 Kg (inclusive)
4.Patients must have a clinical indication to undergo scheduled FFR-guided PCI. We will include two types of stable patients:
1) purely stable patients undergoing scheduled FFR-guided PCI of any vessel
2) patients presenting initially with acute coronary syndrome, with an intermediate coronary lesion (40%-80% in severity, where functional evaluation with FFR must be used on clinical grounds) in a non-culprit artery, and needing staged FFR-guided PCI (at least one month after the ACS)
5.Patients may be already on treatment with either Ticagrelor (mainly previous ACS patients) or Clopidogrel (purely stable patients)

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Known hypersensitivity to aspirin, clopidogrel, ticagrelor or any excipients
2.Concomitant oral anticoagulant therapy, or likely need for it (e.g. atrial fibrillation)
3.Need for concomitant cardiac procedure, such as valve repair or replacement
4.Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm)
5.Any active pathological 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
6.Concomitant oral or IV therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers. Any of such concomitant treatment will be mapped and evaluated by the Investigator in order to comply with the exclusion criteria
7.Increased risk of bradycardia events
8.Known pregnancy and/or breast-feeding
9.Severe uncontrolled chronic obstructive pulmonary disease
10.Concomitant theophylline/aminophylline use
11.Baseline ECG with serious conduction abnormalities (i.e. LVH with repolarization abnormality, left bundle branch block, ST-segment
12.Evidence of prior myocardial infarction by cardiac imaging in the territory of the index vessel
13.Depressed left ventricular systolic function at randomization (ejection fraction < 40% within 48 hours before index PCI)
14.Clinical congestive heart failure
15.Presence of coronary collaterals on diagnostic coronary angiography
16.Diffuse obstructive disease (= 70% stenosis) in the distal segment of the target vessel
17.Left main and/or three-vessel coronary artery disease
18.End-stage renal disease
19.Known severe hepatic impairment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified