EUCTR2016-004746-28-ITActive, not recruitingPhase 1
Ticagrelor And PrEconditioning in patients with stable coronaRy artery diSease:a randomized pilot trial (TAPER-S trial) - TAPER-S
IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI0 sites100 target enrollmentStarted: March 14, 2019Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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