Postoperative Atrial FibrillationPhase 4NCT06151652
Effect of Alpha-Lipoic Acid Supplementation on the Incidence of Postoperative Atrial Fibrillation in Cardiac Surgery Patients
A Phase 4 study testing Alpha Lipoic Acid 600 MG Oral Tablet in people with Postoperative Atrial Fibrillation, run by Ain Shams University at 1 site in Egypt.
Trial summary
ALA is administered orally since it is without difficulty absorbed in the stomach. ALA goes through the blood brain barrier and does not show toxic effects and actions at doses used for prophylactic and therapeutic purposes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Atrial Fibrillation
- What is being tested?
- Alpha Lipoic Acid 600 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I
- Male or female patients above 18 years of age who are scheduled for cardiac surgery.
Who cannot join
- Any urgent or emergency surgery.
- Poor Left ejection volume (EF < 30%).
- Intake of steroids or any antiarrhythmic drugs except beta blockers during the last month before surgery
- Unable or unwilling to provide informed written consent.
- Pregnancy or lactation
- Known hypersensitivity to the study drug.
Show all 9Show fewer
- Current treatment with antioxidants or alpha-lipoic acid for any indication.
- Infection or inflammatory disease except coronary artery disease.
- Left atrium size >70 mm.
Trial locations and contacts
1 site in 1 country.
Marwa Adel, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo
noha tarek, 01007541786
About this study
ALA is administered orally since it is without difficulty absorbed in the stomach. ALA goes through the blood brain barrier and does not show toxic effects and actions at doses used for prophylactic and therapeutic purposes. This has encouraged us to use an efficient anti-oxidant and anti-inflammatory agent, alpha-lipoic acid (biochemical) as a relevant option to prevent POAF.
Read the detailed description
Investigators computed on the basis of findings from a prior study found the incidence of POAF after cardiac surgery of about 25% . Assuming a slightly lower alpha-lipoic acid' effect to previous study. If the true relative risk of AF for experimental subjects relative to controls is 0.5 , with α equivalent to 0.5 and power (1 - β) is 0.8, the estimated sample size is 152 experimental subjects and 152 control subjects in order to be able to reject the null hypothesis that this relative risk equals 1 with probability (power) of 0.8. investigators used the uncorrected chi-squared statistics to evaluate this null hypothesis. STATA software version and taking into account a possible dropout of 15%, the total sample size was: 304 + 0.15 (304) × 2 = 350 subjects of which there will be 175 controls and 175 experimental subjects %, assuming an enrolment ratio of 1:1.
- Conditions
- Postoperative Atrial Fibrillation
- Being tested
- Alpha Lipoic Acid 600 MG Oral Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic Acid 600 MG Oral TabletDrug
Alpha-lipoic acid (Thiotacid 600 mg ®) at a dose of 600 mg three times daily for one day prior to surgery, followed by Alpha-lipoic acid 600 mg twice daily for 5 days post-surgery plus the standard care.
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control group, N = 175 patients) | Placebo comparator | which will include patients adopted to the hospital standard of care. Receives: Drug: Placebo |
| Group 2 (Test group, N = 175 patients) | Active comparator | which will include patients who will receive Alpha-lipoic acid (Thiotacid 600 mg ®) at a dose of 600 mg three times daily for one day prior to surgery, followed by Alpha-lipoic acid 600 mg twice daily for 5 days post-surgery plus the standard care. Receives: Drug: Alpha Lipoic Acid 600 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Number of Participants with POAF
Measured: 1 month
Secondary outcomes (6)
Total intensive care unit length-of-stay
number of days at intensive care unit
Measured: 3 months
Total hospital length-of-stay
number of days at hospital
Measured: 3 months
30 days mortality
deaths number
Measured: 1-month
Serum creatinine
creatinine level
Measured: 5 days
Major adverse cardiovascular outcomes
(Myocardial injury - Stroke - Permanent pacemaker - Pericardial effusion and pleural effusion- Bleeding)
Measured: 1 month
Duration of ventilation
hours needed to remove ventilator
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jan 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwa Adel, PhD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151652
- Sponsor's protocol ID
- ALA post cardiac surgery
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alpha-Lipoic Acid Supplementation on the Incidence of Postoperative Atrial Fibrillation in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06151652
- Acronym / sponsor ID
- ALA post cardiac surgery
- Conditions
- Postoperative Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ALA is administered orally since it is without difficulty absorbed in the stomach. ALA goes through the blood brain barrier and does not show toxic effects and actions at doses used for prophylactic and therapeutic purposes. This has encouraged us to use an efficient anti-oxidant and anti-inflammatory agent, alpha-lipoic acid (biochemical) as a relevant option to prevent POAF.
Detailed description
Investigators computed on the basis of findings from a prior study found the incidence of POAF after cardiac surgery of about 25% . Assuming a slightly lower alpha-lipoic acid' effect to previous study. If the true relative risk of AF for experimental subjects relative to controls is 0.5 , with α equivalent to 0.5 and power (1 - β) is 0.8, the estimated sample size is 152 experimental subjects and 152 control subjects in order to be able to reject the null hypothesis that this relative risk equals 1 with probability (power) of 0.8. investigators used the uncorrected chi-squared statistics to evaluate this null hypothesis. STATA software version and taking into account a possible dropout of 15%, the total sample size was: 304 + 0.15 (304) × 2 = 350 subjects of which there will be 175 controls and 175 experimental subjects %, assuming an enrolment ratio of 1:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control group, N = 175 patients) | Placebo comparator | Drug: Placebowhich will include patients adopted to the hospital standard of care. |
| Group 2 (Test group, N = 175 patients) | Active comparator | Drug: Alpha Lipoic Acid 600 MG Oral Tabletwhich will include patients who will receive Alpha-lipoic acid (Thiotacid 600 mg ®) at a dose of 600 mg three times daily for one day prior to surgery, followed by Alpha-lipoic acid 600 mg twice daily for 5 days post-surgery plus the standard care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- I
- Male or female patients above 18 years of age who are scheduled for cardiac surgery.
Key exclusion criteria (9 listed)
- Any urgent or emergency surgery.
- Poor Left ejection volume (EF < 30%).
- Intake of steroids or any antiarrhythmic drugs except beta blockers during the last month before surgery
- Unable or unwilling to provide informed written consent.
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Lipoic Acid 600 MG Oral TabletAlpha-lipoic acid (Thiotacid 600 mg ®) at a dose of 600 mg three times daily for one day prior to surgery, followed by Alpha-lipoic acid 600 mg twice daily for 5 days post-surgery plus the standard care. | Drug | Group 2 (Test group, N = 175 patients) |
| Placeboplacebo | Drug | Group 1 (Control group, N = 175 patients) |
Primary outcome
• Number of Participants with POAF
Time frame: 1 month
6 secondary outcomes
Total intensive care unit length-of-stay
Time frame: 3 months
Total hospital length-of-stay
Time frame: 3 months
30 days mortality
Time frame: 1-month
Serum creatinine
Time frame: 5 days
Major adverse cardiovascular outcomes
Time frame: 1 month
Duration of ventilation
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Adel, PhD contact
Marwa Adel, PhD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alpha Lipoic Acid 600 MG Oral Tablet in people with Postoperative Atrial Fibrillation, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact noha tarek mohammed, MSC (00201007541786, noha.tarek20@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Number of Participants with POAF (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.