Investigating the combination of Q10 supplement with statin in reducing lipid profile and preventing the occurrence of statin complications in patients with acute coronary syndrome
the effect of coenzyme Q10 supplementation along with atorvastatin on lipid profile and reducing statin side effects in patients with acute coronary syndrome
Design
A controlled, parallel-group, two-blind, randomized, phase 2 clinical trial on 300 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Patients are randomly divided into two control groups (75 people) and intervention (225 people). Patients in the intervention group received a total of 200 mg of CoQ10 supplement daily in the form of 2 divided doses per day for 12 weeks, and the control group did not receive CoQ10 supplement. The study is done in a two-way blind way, and none of the patients, and statistical analysts know which group the patients are in. The participants of the study are followed up by telephone calls every 2 weeks in terms of regular supplement consumption.
Participants/Inclusion and exclusion criteria
confirmed ACS diagnosis, age less than 70 years and being treated with atorvastatin 80mg daily) with full consent (patient or patient's companion), non-entry conditions include pregnancy, breastfeeding, acute kidney injury, GFR <30 ml/min or taking any type of supplement or lipid-lowering drug except atorvastatin with a daily dose of 80 mg, underlying liver disease and high liver enzymes in the initial tests), taking less than 90% of the prescribed supplements or lack of satisfaction The direction will be to participate in the study.
Intervention groups
Patients in the intervention group received a total of 200 mg of CoQ10 supplement daily in the form of 2 divided doses per day for 12 weeks, and the control group did not receive CoQ10 supplement.
Main outcome variables
Reducing the side effects of statins
General information
Reason for update
Acronym
ACS
IRCT registration information
IRCT registration number:IRCT20240609062058N1
Registration date:2024-07-11, 1403/04/21
Registration timing:registered_while_recruiting
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Zahra Hosseinizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3389 9837
Email address
zahra_hosseinizade@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the combination of Q10 supplement with statin in reducing lipid profile and preventing the occurrence of statin complications in patients with acute coronary syndrome
Public title
Effect of Q10 supplementation with statins on lipid profile control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed ACS diagnosis
Age less than 70 years
Complete satisfaction (patient or patient's companion)
Exclusion criteria:
pregnancy
breastfeeding
GFR<30 ml/min
acute kidney injury
Taking any type of supplement or lipid-lowering drug except atorvastatin with a daily dose of 80 mg
underlying liver disease and high liver enzymes in initial tests
Consumption of less than 90% of prescribed supplements
Lack of consent to participate in the study
Age
To 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with definite diagnosis of acute coronary syndrome will be divided into two clusters of Modares Hospital and Shahada Tajrish Hospital, and then the patients will be numbered. In the next step, patients with even numbers will be randomly selected from both clusters and will be divided into intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomly divided into two groups, one group receiving atorvastatin plus placebo and the other group receiving atorvastatin plus Q10 supplement. Patients and their doctors do not know the type of drug protocol received, only the third person who is not directly involved in the study knows the type of drug received by each patient in the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Intervention group: In this group, patients will receive a total of 200mg of CoQ10 supplement (made by Burst Health, USA) in the form of 2 divided doses per day for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients will be given CoQ10 supplement in the form of a placebo until it is equal to the original drug in terms of form, in the same way, in 2 divided doses per day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tajrish Shohada Hospital
Full name of responsible person
Mehdi Pishgahi
Street address
Tehran, Tajrish Sqr, Shahrdari Street
City
Tehran
Province
Tehran
Postal code
989934148
Phone
+98 21 2271 8001
Email
mp_cr1@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdi Pishgahi
Street address
Tehran, Tajrish Sqr, Shahrdari Street.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
mp_cr1@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Hosseinizade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.38, Nori Ave, Dezashib Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 3389 9837
Fax
Email
zahra_hosseinizade@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Hosseinizade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.38, Nori Ave, Dezashib Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 3389 9837
Fax
Email
zahra_hosseinizade@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Hosseinizade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.38, Nori Ave, Dezashib Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 3389 9837
Fax
Email
zahra_hosseinizade@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD