Alpha Lipoic Acid Effect on No-Reflow Phenomenon

NCT05360602 | Completed

• 1 other identifier: NRF-123
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized, open-label, controlled clinical trial to evaluate the efficacy and tolerability of Alpha Lipoic Acid administration on oxidative stress, inflammatory markers, clinical outcome and occurrence of No-Reflow in post myocardial infarction (MI) patients by assessment of aldehyde dehydrogenase-2 (ALDH2) as a marker of oxidative stress and paraoxonase-1 (PON-1) as a marker of oxidative stress and inflammation.

Conditions

No-Reflow Phenomenon

Keywords

No-Reflow Phenomena; Alpha Lipoic Acid; Paraoxonase-1; Aldehyde dehydrogenase-2; Myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Occurrence of No-Reflow phenomena

  To study the effect of Alpha Lipoic Acid administration on the occurrence of No-Reflow phenomena in post-myocardial infarction patients

  During 1 week post PCI

Secondary Outcomes (3)

• Evaluation of markers that reflect oxidative stress and inflammation.

  Baseline, 24 hours, and 7 days post PCI

• Occurrence of MACE.

  up to 4 weeks post PCI.

• Tolerability of Alpha Lipoic Acid administration

  During 4 week post PCI

Study Arms (2)

Control group

EXPERIMENTAL

35 STEMI patients undergoing PCI who will receive standard of care that will include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.

Drug: The standard care for post-PCI MI

Test group

EXPERIMENTAL

35 STEMI patients undergoing PCI who will receive the standard of care in addition to IV Alpha Lipoic Acid 600 mg before PCI then 600 mg orally for 28 days after PCI

Dietary Supplement: Alpha Lipoic Acid plus the standard care for post-PCI MI

Interventions

Alpha Lipoic Acid plus the standard care for post-PCI MI DIETARY_SUPPLEMENT

Intravenous and oral administration of Alpha Lipoic Acid 600 mg plus the standard care for post-PCI MI which will include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.

Also known as: Dietary supplement plus standard care per guidelines for post-PCI MI

Test group

The standard care for post-PCI MI DRUG

will include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.

Also known as: Guidelines MI management

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male aged \>18
• STEMI patients undergoing PCI

You may not qualify if:

• Patients with a recent history of myocardial infarction (MI), a previous PCI or a previous coronary artery bypass graft
• A late presentation (\>12 h), unsuccessful primary PCI (residual stenosis \>50% in the culprit lesion after procedure)
• Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI
• Infectious or inflammatory disease
• Severe liver or renal disease, (AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN), (CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
• Neoplasm, or hematological disorders
• Pregnant or breast-feeding patients
• Active participation in another clinical study
• Patients taking Alpha Lipoic Acid.
• Systolic Blood pressure \<90

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams hospitals

Cairo, Egypt

Location

Related Publications (7)

• Choudhary S. Association of syntax score with short-term outcomes among acute ST-elevation myocardial infarction patients undergoing primary PCI. Indian Heart J. 2017 Apr;69 Suppl 1(Suppl 1):S20-S23. doi: 10.1016/j.ihj.2016.08.002. Epub 2016 Aug 24.

  PMID: 28400034 BACKGROUND

• Mazhar J, Mashicharan M, Farshid A. Predictors and outcome of no-reflow post primary percutaneous coronary intervention for ST elevation myocardial infarction. Int J Cardiol Heart Vasc. 2015 Nov 6;10:8-12. doi: 10.1016/j.ijcha.2015.11.002. eCollection 2016 Mar.

  PMID: 28616509 BACKGROUND

• Kloner RA. No-reflow phenomenon: maintaining vascular integrity. J Cardiovasc Pharmacol Ther. 2011 Sep-Dec;16(3-4):244-50. doi: 10.1177/1074248411405990.

  PMID: 21821523 BACKGROUND

• Ndrepepa G, Tiroch K, Fusaro M, Keta D, Seyfarth M, Byrne RA, Pache J, Alger P, Mehilli J, Schomig A, Kastrati A. 5-year prognostic value of no-reflow phenomenon after percutaneous coronary intervention in patients with acute myocardial infarction. J Am Coll Cardiol. 2010 May 25;55(21):2383-9. doi: 10.1016/j.jacc.2009.12.054.

  PMID: 20488311 BACKGROUND

• Fearon IM, Faux SP. Oxidative stress and cardiovascular disease: novel tools give (free) radical insight. J Mol Cell Cardiol. 2009 Sep;47(3):372-81. doi: 10.1016/j.yjmcc.2009.05.013. Epub 2009 May 28.

  PMID: 19481547 BACKGROUND

• Aviram M, Rosenblat M, Bisgaier CL, Newton RS, Primo-Parmo SL, La Du BN. Paraoxonase inhibits high-density lipoprotein oxidation and preserves its functions. A possible peroxidative role for paraoxonase. J Clin Invest. 1998 Apr 15;101(8):1581-90. doi: 10.1172/JCI1649.

  PMID: 9541487 BACKGROUND

• Wang X, Yu Y, Ji L, Liang X, Zhang T, Hai CX. Alpha-lipoic acid protects against myocardial ischemia/reperfusion injury via multiple target effects. Food Chem Toxicol. 2011 Nov;49(11):2750-7. doi: 10.1016/j.fct.2011.07.065. Epub 2011 Aug 6.

  PMID: 21843584 BACKGROUND

MeSH Terms

Conditions

No-Reflow Phenomenon; Myocardial Infarction

Interventions

Thioctic Acid; Dietary Supplements

Condition Hierarchy (Ancestors)

Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Necrosis

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ayman M Saleh, MD

  Faculty of Medicine, Ain Shams University

  STUDY DIRECTOR

• Lamiaa M El Wakeel, PhD

  Faculty of Pharmacy, Ain Shams University

  STUDY DIRECTOR

• Marwa Adel Ahmed, PhD

  Faculty of Pharmacy, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Omar Ragab

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: May 4, 2022
• Study Start: January 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: January 31, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)