Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial

Universitas Diponegoro50 enrolled

Overview

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 ST-Elevation Myocardial Infarction (STEMI) and are undergoing a procedure known as primary percutaneous coronary intervention (PPCI). Curcumin, a natural compound from turmeric, is known for its antioxidant and anti-inflammatory effects, but it is not easily absorbed by the body. Piperine, a compound from black pepper, can improve curcumin absorption. By combining the two, we hope to maximize their potential benefits. The study will measure markers of inflammation (high-sensitivity C-reactive protein, hsCRP) and oxidative stress (malondialdehyde, MDA) at three time points: before treatment, shortly after the PPCI procedure, and after 28 days of supplementation. The main question is whether curcumin-piperine supplementation can provide additional protection against inflammation and oxidative stress compared to a placebo, potentially supporting recovery and reducing the risk of future heart problems.

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.

Interventions

Curcumin plus PiperineDIETARY_SUPPLEMENT

A loading dose of 2 capsules (each containing 390 mg curcumin + 20 mg piperine) is administered orally prior to PPCI, followed by maintenance of 1 capsule daily until day 28. Oral administration of standardized curcumin extract (390 mg) combined with piperine (20 mg), given twice daily for 28 days in addition to standard-of-care therapy for STEMI patients undergoing primary percutaneous coronary intervention (PPCI). The curcumin-piperine formulation is used to enhance bioavailability and anti-inflammatory effects, aiming to improve post-MI recovery and reduce oxidative stress.

Placebo capsulesOTHER

A loading dose of 2 capsules (each containing saccarum lactic) is administered orally prior to PPCI, followed by maintenance of 1 capsule daily until day 28. Oral administration of standardized placebo capsule, given twice daily for 28 days in addition to standard-of-care therapy for STEMI patients undergoing primary percutaneous coronary intervention (PPCI).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from Baseline in Serum High-Sensitivity C-Reactive Protein (hsCRP) at Day 28

Mean change (Δ) in serum hsCRP from baseline to Day 28, expressed in mg/L. Lower values indicate less systemic inflammation. The prespecified metric is group-wise mean change and between-group difference in mean change.

Time frame: Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention

Change from Baseline in Malondialdehyde (MDA) at Day 28

Mean change (Δ) in serum MDA concentration from baseline to Day 28, expressed in nmol/mL. Lower values indicate less lipid peroxidation/oxidative stress. The prespecified metric is group-wise mean change and between-group difference in mean change.

Time frame: Baseline (pre-intervention), within 48-72 hours post-PPCI and after 28 days of intervention

Secondary Outcomes

Liver Function

To assess changes in liver enzyme activity (ALT and AST) as a marker of hepatic safety and potential hepatoprotective effect of curcumin-piperine supplementation. Unit of Measure: U/L.

Time frame: Baseline and after 28 days of intervention

Change in Serum Creatinine Levels

Serum creatinine will be measured to evaluate kidney function at baseline and after 28 days of supplementation. Unit of Measure: mg/dL.

Time frame: Baseline and after day 28 of intervention

Change in Estimated Glomerular Filtration Rate (eGFR)

eGFR will be calculated using the CKD-EPI formula to assess kidney function at baseline and after 28 days of supplementation. Unit of Measure: mL/min/1.73 m².