Alpha Lipoic Acid Effect on No-Reflow Phenomenon

Study Overview
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Brief Summary
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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
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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

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

Conditions
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No-Reflow Phenomenon

Intervention / Treatment
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* Dietary Supplement: Alpha Lipoic Acid plus the standard care for post-PCI MI
* Drug: The standard care for post-PCI MI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male aged >18 and < 75 years STEMI patients undergoing PCI Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>30 STEMI patients undergoing PCI who will receive standard of care for 1 week 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<br>* 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.<br>* Other names: Guidelines MI management;|
| Experimental: Test group<br>30 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 1 week after PCI | Dietary Supplement: Alpha Lipoic Acid plus the standard care for post-PCI MI<br>* 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.<br>* Other names: Dietary supplement plus standard care per guidelines for post-PCI MI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Occurrence of MACE. | re-infarction, stroke, cardiovascular hospitalisation, and death. | up to 4 weeks post PCI. | 
| Tolerability of Alpha Lipoic Acid administration | Occurrence of adverse drug effects | During 1 week post PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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No-Reflow Phenomena, Alpha Lipoic Acid, Paraoxonase-1, Aldehyde dehydrogenase-2, Myocardial infarction