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Not Yet RecruitingPhase 3ACTRN12625001161415

PDE-5 inhibition in Ischaemia with Non-Obstructive Coronary Arteries: a double-blinded, randomised, placebo-controlled trial (PERTINENT)

Sponsor

Sydney Local Health District

Enrollment

30 participants

Start Date

Nov 3, 2025

Study Type

Interventional

Conditions

IschaemiaNon obstructive coronary artery disease

Summary

A large proportion of INOCA (ischaemia with non-obstructive coronary arteries) patients continue to have symptoms despite being on multiple medications. Sildenafil was studied in a small international study in 2011 which showed some early promising results. However, to the best of our knowledge, there have been no subsequent studies using Sildenafil to treat INOCA. The purpose of this study is to see if Sildenafil improves INOCA symptoms.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • Age >18
  • Non-obstructive coronary artery disease (CAD)
  • Confirmed diagnosis of vasospastic and/or microvascular angina on previous functional coronary angiography (defined as: CFR < 2.5 and/or IMR > 25 and/or epicardial and/or microvascular spasm)
  • >2 angina episodes per week despite maximally tolerated standard anti-anginal therapy

Exclusion Criteria12

  • Previous intolerance to PDE-5 inhibitors due to drug adverse effects
  • Pregnant or breastfeeding women
  • Renal impairment (eGFR < 30mL/min)
  • Severe valvular heart disease
  • Previous priaprism
  • Blood pressure < 90/60mmHg or >170/110mmHg
  • Severe hepatic impairment
  • Recent stroke or myocardial infarction
  • Sickle cell disease
  • Concurrent use of green tea extract
  • Known hereditary degenerative retinal disorders (eg Retiniis pigmentosa)
  • Contraindications to functional coronary angiography

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Interventions

Participants will be randomised to sildenafil 50mg oral tablet twice daily and placebo in 1:1 fashion for a total of 8 weeks. They will have regular follow-up visits and verbal confirmation to assess

Participants will be randomised to sildenafil 50mg oral tablet twice daily and placebo in 1:1 fashion for a total of 8 weeks. They will have regular follow-up visits and verbal confirmation to assess adherence. All participants will undergo treadmill exercise stress testing at baseline and at the end of drug intervention. All participants will undergo coronary angiography with comprehensive physiology testing upon completion of drug intervention.

Locations(1)

NSW, Australia

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ACTRN12625001161415