Background
Rationale
Activation of preconditioning
Improvement of coronary microvascular dysfunction
Pharmacology
Mechanism of action (taken from the SmPC of the drug in study)
Objectives
Primary objective
Secondary objectives
Study endpoints
Primary endpoint
Secondary endpoints
Materials/Methods
TAPER-S trial design
Sample size
Study population
Patient selection
Inclusion criteria
Exclusion criteria
Study drugs
Dosing, posology, and route of administration
Antiplatelet drug switch
Compliance
Discontinuation/stopping of the treatment
Data collection and management
Inspections
Study procedures
Visit scheduling
Randomization
Study timeline
Screening and Randomization | |
V0 – Days -3 to -1 | |
Signed and dated Informed Consent obtained prior to start any procedure scheduled for the study | |
Verification and confirmation of the inclusion/exclusion criteria | |
Randomization | |
Demographics, medical history | |
Physical Examination | |
Vital Signs (BP, HR) | |
NYHA Class definition | |
Pregnancy Test (serum test or urine test as per decision of the clinician) | |
Full Blood Count, Chemistry and Coagulation Tests | |
ECG | |
Echocardiography, if not performed within the last year from the Informed Consent signature | |
Chest X-Ray | |
VASP and VerifyNow Test | |
Dyspnea Evaluation | |
Drug Dispensing | |
Drug Accountability | |
Concomitant Medications | |
Adverse Events | |
Index PCI | |
V1 – Day 0 | |
Verification and confirmation of the inclusion/exclusion criteria | |
Vital Signs (BP, HR) | |
ECG | |
Ischemic Preconditioning | |
Quantification of coronary microvascular resistance | |
VASP and VerifyNow Test | |
VAS Scale Evaluation | |
Dyspnea Evaluation | |
Drug Dispensing | |
Drug Accountability | |
Concomitant Medications | |
Adverse Events | |
Follow-up | |
V2 – Day 1 | |
Physical Examination | |
Vital Signs (BP, HR) | |
ECG | |
VASP and VerifyNow Test | |
Dyspnea Evaluation | |
Drug Dispensing | |
Drug Accountability | |
Concomitant Medications | |
Adverse Events | |
Pre-discharge Visit | |
V3 – Day 2 | |
Physical Examination | |
Vital Signs (BP, HR) | |
Dyspnea Evaluation | |
Drug Dispensing | |
Drug Accountability | |
Concomitant Medications | |
Adverse Events | |
Discharge/End of Study Visit | |
V4 – Day 3 to Day 5 | |
Physical Examination | |
Vital Signs (BP, HR) | |
ECG | |
Full Blood Count, Chemistry and Coagulation Tests | |
Dyspnea Evaluation | |
Drug Dispensing | |
Drug Accountability | |
Concomitant Medications | |
Adverse Events |