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NCT Number: NCT05360602

Alpha Lipoic Acid Effect on No-Reflow Phenomenon

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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Key information

Conditions

No-Reflow Phenomenon Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams hospitals

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male aged >18
  • 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.
  • Systolic Blood pressure <90

Treatment and study plan

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

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.

Other names: Dietary supplement plus standard care per guidelines for post-PCI MI

The standard care for post-PCI MI

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.

Other names: Guidelines MI management

Primary outcomes

  1. Occurrence of No-Reflow phenomena

    Time frame: 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 outcomes

  1. Evaluation of markers that reflect oxidative stress and inflammation.

    Time frame: 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.

  2. Occurrence of MACE.

    Time frame: up to 4 weeks post PCI.

    re-infarction, stroke, cardiovascular hospitalisation, and death.

  3. Tolerability of Alpha Lipoic Acid administration

    Time frame: During 4 week post PCI

    Occurrence of adverse drug effects

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 4, 2022
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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