Statin Adverse ReactionNCT04069598
Statin Intolerance in Patients With Myocardial Infarction
An observational study of Statin Adverse Reaction, run by Turkish Society of Cardiology at 4 sites in Turkey (Türkiye).
Trial summary
Patients with acute coronary syndrome (MI, NSTEMI, USAP) will be included. They will be screened for statin intolernace for 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Statin Adverse Reaction
- What is being tested?
- Statin intolerance test
- How many people
- 600 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 26 Aug 2019to 31 Mar 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Acute coronary syndrome patients
Who may be able to join
- Acute coronary syndrome
Who cannot join
- Being on statin, having statin related side effects
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Haseki
Istanbul
Umit Y Sinan, 0212) 459 20 00, drumityasar@hotmail.com
- Recruiting
Siyami Ersek
Istanbul
Barış Güngör, +90(216) 542 44 44, barisgungor@gmail.com
- Recruiting
Tepecik
Izmir
Oner Ozdogan, +90 232 469 69 69, onerozdogan@yahoo.com
- Recruiting
Ozcan Basaran
Muğla, 48000
Ozcan Basaran, +905065359013, basaran_ozcan@yahoo.com
About this study
Patients with acute coronary syndrome (MI, NSTEMI, USAP) will be included. They will be screened for statin intolernace for 6 months.
- Conditions
- Statin Adverse Reaction
- Being tested
- Statin intolerance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin intolerance testDiagnostic test
Statin intolerance test
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin intolerance
Number (percentage) of patients with statin intolerance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 Aug 2019
- Primary completion2 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statin Adverse ReactionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069598
- Sponsor's protocol ID
- A-HIT 4-SI Study
- Status last verified
- Sep 2019
- First submitted
- 23 Aug 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Intolerance in Patients With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04069598
- Acronym / sponsor ID
- A-HIT 4-SI Study
- Conditions
- Statin Adverse Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Turkish Society of CardiologyUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 2 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 28 Aug 2019 (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.
Patients with acute coronary syndrome (MI, NSTEMI, USAP) will be included. They will be screened for statin intolernace for 6 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute coronary syndrome patients
Key inclusion criteria (1 listed)
- Acute coronary syndrome
Key exclusion criteria (1 listed)
- Being on statin, having statin related side effects
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 |
|---|---|---|
| Statin intolerance testStatin intolerance test | Diagnostic test | – |
Primary outcome
Statin intolerance
Time frame: 6 months
Number (percentage) of patients with statin intolerance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Statin Adverse Reaction, run by Turkish Society of Cardiology at 4 sites in Turkey (Türkiye).
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 1 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 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statin intolerance (time frame: 6 months). 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 12 Sep 2019.