Status:

COMPLETED

Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial

Lead Sponsor:

Universitas Diponegoro

Collaborating Sponsors:

Dr. Kariadi Hospital Semarang, indonesia

Conditions:

ST Elevation Myocardial Infarction (STEMI)

Malondialdehyde

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

This study aims to evaluate whether supplementation with a combination of curcumin and piperine can help reduce inflammation and oxidative stress in patients who have experienced a heart attack called...

Detailed Description

This randomized, double-blind, placebo-controlled clinical trial investigates the effects of combined curcumin and piperine supplementation on systemic inflammation and oxidative stress in patients wi...

Eligibility Criteria

Inclusion

  • Adults aged 18 to 80 years.
  • Confirmed diagnosis of ST-Elevation Myocardial Infarction (STEMI). Symptom onset within 12 hours, or within 12 to 72 hours in cases with an indication for primary percutaneous coronary intervention (PPCI).
  • Receiving standard-of-care medical therapy according to current guidelines, including:
  • Dual antiplatelet therapy. Angiotensin-Converting Enzyme Inhibitors (ACE-i) or Angiotensin Receptor Blockers (ARBs).
  • Statins. Beta-blockers.

Exclusion

  • Regular prior use of curcumin supplementation.
  • Hemodynamic instability or severe dyspnoea with clinical signs of congestion (elevated jugular venous pressure, pulmonary rales affecting \>1/3 of lung fields, hepatomegaly, ascites, or peripheral oedema).
  • History of prior myocardial infarction, previous percutaneous coronary intervention, or coronary artery bypass graft surgery.
  • Known hypersensitivity to curcumin or piperine.
  • Active malignancy.
  • Chronic infections (e.g., hepatitis, tuberculosis, or HIV).
  • Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or rapidly declining renal function.

Key Trial Info

Start Date :

February 5 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 20 2025

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07149961

Start Date

February 5 2025

End Date

May 20 2025

Last Update

September 2 2025

Active Locations (1)

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Universitas Diponegoro

Semarang, Central Java, Indonesia, 50275