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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

Inclusion Criteria11

  • Chronic Refractory Angina is continuing despite conventional anti anginal therapy, ie:
  • Beta Blocker, Calcium channel blocker, Long acting nitroglycerin, nicorandil
  • CAD is not amenable to revascularisation therapy
  • There has been a stable anginal pattern over the past month
  • defined as:
  • (a) Objective evidence of coronary artery disease (1mm ST depression on stress ECG test, reversible defect on stress myocardial scintigraphy, or >70% coronary stenosis on angiography)
  • (b) Continuing angina despite ‘conventional antianginal therapy’. That is, patients must have been shown to be treated with or not treated with due to intolerance/contraindicated/ inefficacy to a beta blocker (BB) AND treated with or not treated with due to intolerance/contraindicated/inefficacy a calcium channel blocker (CCB) AND treated with or not treated with due to intolerance/ contraindicated/ inefficacy a long acting nitrate (LAN) AND treated with or not treated with due to intolerance/ contraindicated/ inefficacy nicorandil.
  • (c) Coronary artery disease not amenable to revascularisation therapy either due to unsuitable coronary anatomy or patient characteristics.
  • (d) Stable anginal pattern for the past month.
  • Symptomatic angina with episodes occurring 3 times/week
  • Sinus rhythm

Exclusion Criteria5

  • Patient must not have had an Acute coronary syndrome admission within the past 3 months, or a revascularisation procedure within the past 6 months or planned within the next 3 months.
  • Resting heart rate cannot be under 60bpm on an ECG.
  • Blood pressure must not be under 90/50 mm/Hg.
  • Patients are not allowed to use conomitant non-dyhydropyridine calcium channel blocker therapy.
  • Patient must be able to provide informed consent.

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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