Alpha Lipoic Acid Effect on No-Reflow Phenomenon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-01-31

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.

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Detailed Description

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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

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No-Reflow Phenomenon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

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.

Group Type EXPERIMENTAL

The standard care for post-PCI MI

Intervention Type 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.

Test group

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DRUG

Other Intervention Names

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Dietary supplement plus standard care per guidelines for post-PCI MI Guidelines MI management

Eligibility Criteria

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Inclusion Criteria

1. Female or male aged \>18
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.
10. Systolic Blood pressure \<90

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No