Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial
NCT07149961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-09-02
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 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.
Conditions
- ST Elevation Myocardial Infarction (STEMI)
- Malondialdehyde
- Hs-CRP
- Curcumin
- Curcuma Xanthorrhiza
- High-sensitivity C-reactive Protein
Interventions
- DIETARY_SUPPLEMENT
-
Curcumin plus Piperine
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.
- OTHER
-
Placebo capsules
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).
Sponsors & Collaborators
-
Dr. Kariadi Hospital Semarang, indonesia
collaborator UNKNOWN -
Universitas Diponegoro
lead OTHER
Principal Investigators
-
Fahri Husaini Alkaf, M.D. · Universitas Diponegoro
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-05
- Primary Completion
- 2025-04-25
- Completion
- 2025-05-20
Countries
- Indonesia
Study Locations
More Related Trials
-
Evaluation in STEMI Patients Using FDY-5301
NCT04837001 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
NCT03998319 ·Status: RECRUITING ·Phase: PHASE3
-
The Thrombus Aspiration During PCI After Thrombolysis in STEMI
NCT06654453 ·Status: RECRUITING ·Phase: NA
-
A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
NCT03578809 ·Status: COMPLETED ·Phase: PHASE2
-
Colchicine's Efficacy in MI Patients: Comparing PCI and Non-Reperfusion Approaches
NCT06426537 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI
NCT06678074 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
NCT00611169 ·Status: COMPLETED ·Phase: PHASE4
-
Myocardial Injury After Elective Coronary Stenting
NCT01986621 ·Status: COMPLETED
-
BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention
NCT00111566 ·Status: COMPLETED ·Phase: PHASE4
-
Revascularization StrategIes for ST Elevation Myocardial Infarction Trial
NCT03263468 ·Status: UNKNOWN ·Phase: NA
-
Nitric Oxide Inhalation Therapy to Relieve Chest Pain in Patients With Coronary Artery Disease
NCT00014040 ·Status: COMPLETED ·Phase: PHASE2
-
Adjunctive, Low-dose tPA in Primary PCI for STEMI
NCT03335839 ·Status: COMPLETED ·Phase: PHASE3
-
The RECOVERY Study: Using Supersaturated Oxygen Therapy To Treat Small Vessel Blockages After a Heart Attack
NCT07000266 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients
NCT00945308 ·Status: UNKNOWN ·Phase: PHASE2
-
Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction
NCT05014061 ·Status: WITHDRAWN ·Phase: PHASE3
-
Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
NCT01958034 ·Status: COMPLETED ·Phase: PHASE4
-
Intramyocardial Haemorrhage in Patients With Primary STEMI
NCT03677466 ·Status: COMPLETED ·Phase: NA
-
Post-Marketing Safety Study in ST-Segment Elevation Myocardial Infarction (STEMI) Participants Undergoing Primary Percutaneous Coronary Intervention (PCI) Procedure With VISIPAQUE® as the Contrast Medium
NCT03671603 ·Status: COMPLETED
-
Study to Evaluate the Safety and Activity of BB3 to Treat Heart Attack
NCT01539590 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation
NCT00910962 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)
NCT01324453 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction
NCT01936896 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
The Use of Statins for Myocardial Death Prevention
NCT00772564 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)
NCT00426751 ·Status: COMPLETED ·Phase: PHASE3
-
Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Action on Coronary Microcirculation Dysfunction
NCT05790876 ·Status: COMPLETED ·Phase: NA