Effects of the Ivabradine on Reduction of Inflammatory Markers in Patients With Acute Coronary Syndrome

NCT00815100 | Completed Phase 4 DMC

• 1 other identifier: Riviera/09
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether a pure heart rate-lowering agent (Ivabradine) reduces vascular inflammatory stress in patients with acute coronary syndromes

Conditions

Acute Coronary Syndromes

Keywords

Ivabradine; Acute coronary syndrome.; Inflammation; C-reactive protein; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Whether initiation of ivabradine therapy in patients with acute coronary syndromes immediately after hospital admission decreases high-sensitivity C-reactive protein.

  day 4 and day 30

Secondary Outcomes (1)

• Whether initiation of ivabradine therapy decreases the occurrence of ischemic events (death, nonfatal myocardial infarction, unstable angina, urgent revascularization, cardiac arrest) in patients with acute coronary syndromes.

  day 30, 90, 180 and 360

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Ivabradine

ACTIVE COMPARATOR

Drug: Ivabradine

Interventions

Ivabradine DRUG

Eligible patients will be randomized to 1 of the 2 treatment arms, namely, double-blind ivabradine, or placebo, after hospital admission (at 48 hours). The starting dose of ivabradine will be 5 mg (or matching placebo) twice daily in all patients. Patients receiving 5 mg twice daily (or matching placebo) 1 week after the inclusion with a resting HR of ≥60 beats per minute will receive the target dose of 7.5 mg twice daily (or matching placebo).

Ivabradine

Placebo DRUG

Eligible patients will be randomized to 1 of the 2 treatment arms, namely, double-blind ivabradine, or placebo, after hospital admission (at 48 hours). The starting dose of ivabradine will be 5 mg (or matching placebo) twice daily in all patients. Patients receiving 5 mg twice daily (or matching placebo) 1 week after the inclusion with a resting HR of ≥60 beats per minute will receive the target dose of 7.5 mg twice daily (or matching placebo).

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Age \> 18 years.
• Ischemic symptoms suspected to represent a non-ST segment elevation acute coronary syndrome defined as:
• Clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain occuring at rest or with minimal exertion (lasting longer than 10 min) and planned to be managed with an early invasive strategy with intention to perform a percutaneous coronary intervention as early as possible and not later than 72 hours of randomization, and at least one of the following:
• ECG changes compatible with new ischemia (ST depression of at least 1 mm or transient ST elevation or ST elevation of \<1 mm or T wave inversion \>3 mm in at least 2 contiguous leads; or
• Already elevated cardiac enzymes (eg, CK-MB) or biomarkers (troponin I or T) above the upper limit of normal.
• Patients should be in sinus rhythm with a resting HR of \> 60 beats per minute on a resting standard 12-lead ECG.
• Written informed consent obtained.

You may not qualify if:

• Patients unlikely to cooperate in the study or with inability or unwillingness to give informed consent.
• Pregnant or breast-feeding women or women of childbearing potential.
• Patients with recent (\< 6 months) myocardial infarction or coronary revascularization or with a history of stroke or cerebral transient ischemic attack within the preceding 3 months or scheduled for revascularization (percutaneous coronary intervention and coronary artery bypass graft).
• Patients with at least 1 of the following criteria:
• Implanted pacemaker or implantable cardioverter defibrillator.
• Valvular disease likely to require surgery within the next 2 years.
• Sick sinus syndrome, sinoatrial block, congenital long QT syndrome, complete atrioventricular block.
• Expectation of death from other illness during the course of the trial.
• Known severe liver or renal disease.
• Requiring or likely to require the following medications: macrolide antibiotics, cyclosporin, gestodene, antiretroviral drugs or azole antifungals such as ketoconazole or with known hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• Patients with systemic or cardiac inflammatory processes with the exception of atherosclerosis.

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Inflammation; Atherosclerosis

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2008
• First Posted: December 29, 2008
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: September 7, 2011
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

ES (1)