Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial

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 with ST-Elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Curcumin, the principal curcuminoid derived from Curcuma xanthorrhiza or Curcuma longa, has demonstrated anti-inflammatory and antioxidant properties in preclinical and clinical studies. However, its oral bioavailability is limited due to poor absorption and rapid metabolism. Piperine, an alkaloid from Piper nigrum, enhances curcumin's bioavailability through inhibition of hepatic and intestinal glucuronidation.

Participants are randomized to receive either curcumin-piperine supplementation (390 mg curcumin + 20 mg piperine daily) or matched placebo for 28 consecutive days post-PPCI. Biomarkers of inflammation (high-sensitivity C-reactive protein, hsCRP) and oxidative stress (malondialdehyde, MDA) are assessed at three predefined time points: baseline (pre-intervention), 48-72 hours after PPCI, and at day 28 post-supplementation.

The primary objective is to determine whether curcumin-piperine supplementation significantly attenuates the rise in hsCRP and MDA levels compared to placebo. Secondary objectives include evaluating the temporal pattern of biomarker changes and assessing the tolerability and safety profile of the supplementation in the acute and subacute phases post-STEMI. The findings may provide evidence for adjunctive nutraceutical therapy to improve post-MI recovery by targeting inflammatory and oxidative stress pathways.

Inclusion criteria

• 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 criteria

• 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.