NCT07129850

Brief Summary

Bempedoic acid in PPCI

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Aug 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Aug 2025Nov 2027

First Submitted

Initial submission to the registry

August 12, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2027

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 12, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

Bempedoic acidTNF alphaPPCI

Outcome Measures

Primary Outcomes (1)

  • Change in inflammatory markers

    reactive protein \[CRP\] and tumor necrosis factor-alpha \[TNF-α\]) at 1 month post-primary PCI compared between the intervention group (Bempedoic Acid) and the control group.

    At 1 month post-PCI.

Secondary Outcomes (3)

  • Final TIMI flow grade post-PCI.

    1 day

  • Major Adverse Cardiac Events

    Within 30 days post-PCI.

  • Lipid Profile Changes

    At 1 month post-PCI.

Study Arms (1)

Two groups will be measured

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study Population The study will include patients presenting with ST-elevation myocardial infarction (STEMI) who are eligible for and undergoing primary percutaneous coronary intervention (PCI) at Assiut University Heart Hospital.

You may qualify if:

  • Age ≥18 years STEMI diagnosis Undergoing primary PCI

You may not qualify if:

  • Known allergy to Bempedoic acid Active infection or chronic inflammatory disease Severe hepatic or renal dysfunction Use of immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Laufs U, Banach M, Mancini GBJ, Gaudet D, Bloedon LT, Sterling LR, Kelly S, Stroes ESG. Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019 Apr 2;8(7):e011662. doi: 10.1161/JAHA.118.011662.

  • Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ; CANTOS Trial Group. Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease. N Engl J Med. 2017 Sep 21;377(12):1119-1131. doi: 10.1056/NEJMoa1707914. Epub 2017 Aug 27.

  • Biolo G, Vinci P, Mangogna A, Landolfo M, Schincariol P, Fiotti N, Mearelli F, Di Girolamo FG. Mechanism of action and therapeutic use of bempedoic acid in atherosclerosis and metabolic syndrome. Front Cardiovasc Med. 2022 Oct 28;9:1028355. doi: 10.3389/fcvm.2022.1028355. eCollection 2022.

  • Feingold KR. Guidelines for the Management of High Blood Cholesterol. 2025 Mar 27. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK305897/

  • WHO CVD Risk Chart Working Group. World Health Organization cardiovascular disease risk charts: revised models to estimate risk in 21 global regions. Lancet Glob Health. 2019 Oct;7(10):e1332-e1345. doi: 10.1016/S2214-109X(19)30318-3. Epub 2019 Sep 2.

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Amr Youssef, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Mostafa Sayed Ahmed

CONTACT

Marwan Sayed, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

August 14, 2025

Primary Completion (Estimated)

August 14, 2026

Study Completion (Estimated)

November 14, 2027

Last Updated

August 19, 2025

Record last verified: 2025-08