Status:
COMPLETED
Effects of Ivabradine on Residual Myocardial Ischemia After PCI
Lead Sponsor:
Azienda Policlinico Umberto I
Conditions:
Angina Pectoris, Stable
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is a randomized pharmacological study evaluating the effects of ivabradine in patients with residual angina after PCI. The role of ivabradine in patients with angina, without systolic dysfunction...
Detailed Description
BACKGROUND. Residual angina after PCI is a frequently-occurring disease. Ivabradine improves symptoms but its role in patients without left-ventricular systolic dysfunction is still unclear. The aim w...
Eligibility Criteria
Inclusion
- coronary artery disease with chronic stable angina for more than three months (Canadian Cardiovascular Society-CCS-class I-III);
- percutaneous revascularization with stent implantation at least one;
- signs/symptoms of residual ischemia; sinus rhythm; HR ≥ 70 bpm at rest;
- ability to perform an echocardiogram stress test with the tilting bicycle stress test (BST);
- good acoustic window;
- age ≥ 18 years.
Exclusion
- drugs intolerance or hypersensitivity
- EF ≤ 40 %
- NYHA class III to IV;
- CCS IV
- atrial fibrillation or flutter
- presence of a pacemaker or implantable defibrillator
- II or III degree AV block
- HR ≤ 70 bpm at rest or sick sinus syndrome
- any condition that could interfere with the ability to exercise stress test like Wolff- Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy;
- rate-corrected QT interval (QTc) greater than 500 ms or the use of drugs that prolong the QTc interval
- symptomatic hypotension or uncontrolled hypertension (systolic blood pressure at rest ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)
- severe liver disease and severe renal impairment (creatinine clearance ≤ 30 ml/min)
- electrolyte disorders
- uncontrolled thyroid disease
- pregnancy.
Key Trial Info
Start Date :
March 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03866395
Start Date
March 5 2015
End Date
March 7 2017
Last Update
March 7 2019
Active Locations (1)
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1
Massimo Mancone
Rome, Italy, 00100