Statin DoseNCT04923152
Effective Dose of Statin Post PCI
A study testing moderate statin dose and high dose statin in people with Statin Dose, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
In this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded Read more about this study
- Who is it for?
- Ages 52 to 75 years
- Conditions the study is for
- Statin Dose
- What is being tested?
- moderate statin dose and high dose statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2020to 1 Apr 2021
- Phase
- Interventional
- 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 52 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients who have undergone PCI due to chronic stable angina
Who cannot join
- Patients with acute coronary syndrome
- Primary LDL>190 mg/DL
- Patients who developed statin-induced myopathy or rhabdomyolysis
- Persistent increase in hepatic enzyme levels or hepatic failure
- Pregnancy and breast feeding
- Statin hypersensitivity
- Patients with history of multiple atherosclerotic events
- Patients who received high intensity statin before the study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High- or Moderate-Dose Statin on 1-Year Major Adverse Cardiovascular Events (MACE) Post Percutaneous Coronary Interventions
In this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded
Read the detailed description
In this randomized double-blind clinical trial, the study population was all patients with a recent history of PCI who referred to the professor kojuri cardiovascular clinic for the first post-procedure visit. In the first visit, patients were randomly divided into two groups Both groups were treated with Rosuvastatin 40 mg as high potency statin for one month after PCI. In the first group, after one month, the statin level changed to Rosuvastatin 5 mg daily (moderate intensity). In the second group, 40 mg of Rosuvastatin was continued for one year. Then, the participants were evaluated in terms of MACEs, including any hospitalization due to acute coronary syndrome, as well as history of stroke and myocardial Infarction, subsequent unplanned revascularization and cardiac death. The HS-CRP also checked between two groups
- Conditions
- Statin Dose
- Being tested
- moderate statin dose, high dose statin
- Keywords
- PCI, Stable Angina, statin therapy
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate statin doseDrug
5 mg rosuvastatin per day
high dose statinDrug
40 mg rosuvastatin per day
| Study group | Role | What they receive |
|---|---|---|
| moderate dose statin | Experimental | Patients 1 month post PCI, allocated to 5 mg rosuvastatin per day Receives: Drug: moderate statin dose |
| high dose statin | Active comparator | patients 1 month post PCI, allocated to 40 mg rosuvastatin Receives: Drug: high dose statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events (MACE)
major adverse cardiovascular events
Measured: 1 year
serum level of HS-CRP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statin DoseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923152
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1398.620
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Dat available on demand of reviewer
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High- or Moderate-Dose Statin on 1-Year Major Adverse Cardiovascular Events (MACE) Post Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT04923152
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1398.620
- Conditions
- Statin Dose
- Keywords
- PCI, Stable Angina, statin therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 11 Jun 2021 (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.
In this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded
Detailed description
In this randomized double-blind clinical trial, the study population was all patients with a recent history of PCI who referred to the professor kojuri cardiovascular clinic for the first post-procedure visit. In the first visit, patients were randomly divided into two groups Both groups were treated with Rosuvastatin 40 mg as high potency statin for one month after PCI. In the first group, after one month, the statin level changed to Rosuvastatin 5 mg daily (moderate intensity). In the second group, 40 mg of Rosuvastatin was continued for one year. Then, the participants were evaluated in terms of MACEs, including any hospitalization due to acute coronary syndrome, as well as history of stroke and myocardial Infarction, subsequent unplanned revascularization and cardiac death. The HS-CRP also checked between two groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized
| Arm | Type | Receives |
|---|---|---|
| moderate dose statin | Experimental | Drug: moderate statin dosePatients 1 month post PCI, allocated to 5 mg rosuvastatin per day |
| high dose statin | Active comparator | Drug: high dose statinpatients 1 month post PCI, allocated to 40 mg rosuvastatin |
Who may qualify
- Ages
- 52 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients who have undergone PCI due to chronic stable angina
Key exclusion criteria (8 listed)
- Patients with acute coronary syndrome
- Primary LDL>190 mg/DL
- Patients who developed statin-induced myopathy or rhabdomyolysis
- Persistent increase in hepatic enzyme levels or hepatic failure
- Pregnancy and breast feeding
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 |
|---|---|---|
| moderate statin dose5 mg rosuvastatin per day | Drug | moderate dose statin |
| high dose statin40 mg rosuvastatin per day | Drug | high dose statin |
Primary outcome
major adverse cardiovascular events (MACE)
Time frame: 1 year
major adverse cardiovascular events
serum level of HS-CRP
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No. Dat available on demand of reviewer
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate statin dose and high dose statin in people with Statin Dose, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jun 2021. 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 Iran. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (MACE) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 11 Jun 2021.