Effects of Ivabradine on Residual Myocardial Ischemia After PCI

NCT03866395 | Completed Phase 4 DMC

• 1 other identifier: 04091990
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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, is not yet clear. The investigators performed in all patients an echostress to evaluate the effects of therapy with ivabradine after 30 days in terms of exercise tolerance and diastolic function.

Conditions

Angina Pectoris, Stable

Keywords

Stable angina; coronary artery diseases; heart rate; exercise tolerability; diastolic function; ivabradine

Outcome Measures

Primary Outcomes (4)

• Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg)

  These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.

  30 days

• Triple product (TP), calculated as a product between HR, systolic blood pressure and ejection time. (unit of measure: beats per minute x mmHg x msec)

  These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.

  30 days

• chronotropic reserve (unit of measure: beats per minute)

  difference between resting heart rate and maximum heart rate at peak exercise

  30 days

• muscular work (unit of measure: watt)

  These, indirectly, reflect the myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.

  30 days

Secondary Outcomes (4)

• diastolic function: PW Doppler E wave (unit of measure: cm/sec)

  30 days

• diastolic function: TDI derived E' measurements (unit of measure: cm/sec)

  30 days

• diastolic function: PW Doppler A wave (unit of measure: cm/sec)

  30 days

• E/E' ratio

  30 days

Study Arms (2)

Control Group

NO INTERVENTION

drug therapy according to the guidelines

Ivabradine Group

EXPERIMENTAL

drug therapy according to the guidelines + Ivabradine 5 mg twice a day

Drug: Ivabradine

Interventions

Ivabradine DRUG

Ivabradine 5 mg twice a day

Also known as: Procoralan, Corlentor

Ivabradine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Policlinico Umberto I: lead

Study Sites (1)

Massimo Mancone

Rome, 00100, Italy

Location

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Massimo Mancone

  Department of Cardiovascular disease, Sapienza, University of Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: (MD, PhD) Principal Investigator

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: March 7, 2019
• Study Start: March 5, 2015
• Primary Completion: March 7, 2017
• Study Completion: March 7, 2017
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)