Alpha Lipoic Acid Effect on No-Reflow Phenomenon

No-Reflow Phenomenon Clinical Trial

Official title:

Evaluation of The Effect of Alpha Lipoic Acid Administration on Oxidative Stress Markers and Occurrence of No-Reflow Phenomenon in Post Myocardial Infarction Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05360602
• Other study ID #: NRF-123
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: August 2023

Study information

• Verified date: April 2022
• Source: Ain Shams University
• Contact: Omar Ragab Elsayed, BSc
• Phone: 00201011177942
• Email: omar.ragab[@]pharma.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

All (60) STEMI patients undergoing PCI presenting to the Cardiology department will be randomly assigned into one of 2 arms: 30 patients undergoing PCI who will receive standard of care for 1 week, the other 30 patients undergoing PCI will receive standard of care in addition to Alpha Lipoic Acid 600 mg daily for 1 week. IV Alpha Lipoic Acid 600 mg once daily will be administered prior to PCI then orally daily for 1 week after PCI.

Baseline evaluation included demographics and history taking. After obtaining the informed consent, information including age, weight, height, smoking state, and other diseases e.g. hypertension, diabetes, hyperlipidemias, etc. will be documented for each patient. Medication history in detail, as well as the background cardiovascular treatment, will be considered.

All patients will be followed up regularly during the hospital stay and after discharge, will be assessed for the occurrence of adverse cardiac events and occurrence of adverse effects from medications

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Female or male aged >18 and < 75 years

2. STEMI patients undergoing PCI

Exclusion Criteria:

1. Patients with a recent history of myocardial infarction (MI), a previous PCI or a previous coronary artery bypass graft

2. A late presentation (>12 h), unsuccessful primary PCI (residual stenosis >50% in the culprit lesion after procedure)

3. Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI

4. Infectious or inflammatory disease

5. 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)

6. Neoplasm, or hematological disorders

7. Pregnant or breast-feeding patients

8. Active participation in another clinical study

9. Patients taking Alpha Lipoic Acid.

Related Conditions & MeSH terms

• No-Reflow Phenomenon

Intervention

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

Drug:
• The standard care for post-PCI MI
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (7)

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. — View Citation

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:S20-S23. doi: 10.1016/j.ihj.2016.08.002. Epub 2016 Aug 24. — View Citation

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. Review. Erratum in: J Mol Cell Cardiol. 2009 Nov;47(5):748. — View Citation

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

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. — View Citation

Ndrepepa G, Tiroch K, Fusaro M, Keta D, Seyfarth M, Byrne RA, Pache J, Alger P, Mehilli J, Schömig 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of markers that reflect oxidative stress and inflammation.	Measuring serum concentration of aldehyde dehydrogenase-2 (ALDH2) and paraoxonase-1 (PON-1). ALDH2 reflects oxidative stress, paraoxonase-1 reflects oxidative stress and inflammation.	Baseline and Day 7 post PCI
Secondary	Occurrence of MACE.	re-infarction, stroke, cardiovascular hospitalisation, and death.	up to 4 weeks post PCI.
Secondary	Tolerability of Alpha Lipoic Acid administration	Occurrence of adverse drug effects	During 1 week post PCI