NCT05360602

Alpha Lipoic Acid Effect on No-Reflow Phenomenon

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All (70) STEMI patients undergoing PCI presenting to the Cardiology department will be randomly assigned into one of 2 arms: 35 patients undergoing PCI who will receive standard of care , the other 35 patients undergoing PCI will receive standard of care in addition to Alpha Lipoic Acid 600 mg daily for 4 week. IV Alpha Lipoic Acid 600 mg once daily will be administered prior to PCI then orally daily for 4 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

Conditions

• No-Reflow Phenomenon

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-07-01
• Completion: 2024-01-31
• First posted: 2022-05-04
• Last updated: 2024-11-05

Locations

1 site across 1 country: Egypt