TerminatedPhase 4ACTRN12611000203954

The Ivabradine study - Assessing the benefit of Ivabradine in reducing episodes of angina in patients with chronic refractory angina.

A Placebo-controlled, Randomised, Double-blind, Crossover Study of the Efficacy of Ivabradine in the Management of Chronic Refractory Angina.

Sponsor

The Queen Elizabeth Hospital

Enrollment

30 participants

Start Date

Mar 24, 2011

Study Type

Interventional

Conditions

chronic refractory angina

Summary

Ivabradine is an anti anginal agent, approved by the TGA for use in chronic stable angina. It reduces the heart rate by inhibiting the If current within the SA node. Ivabradine has been shown to increase exercise time and time to ischemic ECG changes. This study will evaluate its efficacy in reducing spontaneous episodes of angina amongst patients with chronic refractory angina.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether ivabradine, a heart rate-lowering medication, can reduce chest pain episodes in patients with chronic angina that has not responded to standard treatments. Participants must have confirmed coronary artery disease that cannot be treated with surgery and must experience at least three episodes of chest pain per week.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Two arms in this study. Randomise to Placebo/Ivabradine 5mg-7.5mg bd (double-blind methodology). Treatment A: placebo/Ivabradine 5mg orally twice daily. Continue therapy over a 2-week period prior

Two arms in this study. Randomise to Placebo/Ivabradine 5mg-7.5mg bd (double-blind methodology). Treatment A: placebo/Ivabradine 5mg orally twice daily. Continue therapy over a 2-week period prior to a titration visit to assess efficacy and tolerability. At 2-week follow-up period, if angina symptoms persist, up-titrate to placebo/ivabradine 7.5mg bd, and continue therapy for 4 weeks until assessment of endpoints. A drug washout period of 2 weeks will then ensue followed by cross-over to alternate study phase and repeat of the above protocol over a 6-week period. Treatment B: One placebo/ivabradine capsule orally twice daily, same as treatment arm A

Locations(1)

SA, Australia

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ACTRN12611000203954