Alpha Lipoic Acid Effect on No-Reflow Phenomenon

Not Applicable

Completed

• Conditions: No-Reflow Phenomenon
• Interventions: Drug: The standard care for post-PCI MI; Dietary Supplement: Alpha Lipoic Acid plus the standard care for post-PCI MI

• Registration Number: NCT05360602
• Lead Sponsor: Ain Shams University

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.

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

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-04-10
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-04
• Primary Completion: 2023-07-01
• Study Completion: 2024-01-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-03
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Female or male aged >18
2. STEMI patients undergoing PCI

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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.
10. Systolic Blood pressure <90

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	The standard care for post-PCI MI	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.
Test group	Alpha Lipoic Acid plus the standard care for post-PCI MI	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

Primary Outcome Measures

Name	Time	Method
Occurrence of No-Reflow phenomena	During 1 week post PCI	To study the effect of Alpha Lipoic Acid administration on the occurrence of No-Reflow phenomena in post-myocardial infarction patients

Secondary Outcome Measures

Name	Time	Method
Evaluation of markers that reflect oxidative stress and inflammation.	Baseline, 24 hours, and 7 days post PCI	Measuring serum concentration of aldehyde dehydrogenase-2 (ALDH2) and paraoxonase-1 (PON-1). ALDH2 reflects oxidative stress, paraoxonase-1 reflects oxidative stress and inflammation.
Occurrence of MACE.	up to 4 weeks post PCI.	re-infarction, stroke, cardiovascular hospitalisation, and death.
Tolerability of Alpha Lipoic Acid administration	During 4 week post PCI	Occurrence of adverse drug effects

Trial Locations

Locations (1)

Ain shams hospitals; 🇪🇬 Cairo, Egypt