StatinsStatinEPICNCT03485742
Statin Eligibility Prior to Myocardial InfarCtion
An observational study of Statins and Myocardial Infarction, run by Jordan Collaborating Cardiology Group at 5 sites in Jordan.
Trial summary
The study (Statin Eligibility Prior to myocardial infarction (MI) in Jordanians, StatinEPIC) is 1. Cross sectional 2. Non interventional 3. One encounter per patient. No follow up. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Statins, Myocardial Infarction
- How many people
- 740 participants
- Where
- 5 sitesJordan
- Study dates
- 22 Apr 2019to 10 Jun 2019
- 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 30 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients aged 30 to 75 years admitted with MI (ST elevation and non ST elevation) who are not receiving statins prior to admission will be evaluated for potential eligibility had they been evaluated prior to admission with MI.
Who may be able to join
- Adults admitted with MI, age 30 to 75
- known lipid profile
Who cannot join
- on statin before enrollment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Jordan5 sites
Istishari Hospital
Amman, 11184
The University of Jordan
Amman, 11942
Jordan Hospital
Amman
Khalidi Hospital & Medical Center
Amman
King Abdullah University Hospital
Irbid
About this study
Official title: Statin Eligibility Prior to Myocardial InfarCtion in Jordanians
The study (Statin Eligibility Prior to myocardial infarction (MI) in Jordanians, StatinEPIC) is
- Cross sectional
- Non interventional
- One encounter per patient. No follow up. It addresses a major issue of primary prevention in Jordanians especially the young population, namely the issue of lipid lowering agents before sustaining an acute MI. A recent study in USA showed that 50% of patients who sustained MI were not eligible to statins had they been evaluated before the heart attack. It is largely unknown if a larger percentage of Middle Eastern patients who sustain a heart attack would be eligible to receive lipid lowering agents.
- The PI will overlook the whole process. Dr Ahmad Tamari, the assistant to the PI will asses this whole process of data collection, management and manuscript drafting.
Read the detailed description
Statins, when use as primary cardiovascular prevention strategy, have been shown to lower future acute cardiovascular events, especially myocardial infarction. However the use of statins in this context (i.e., primary prevention) is governed by guidelines that limit the use of statins to four high risk populations: (1) hose with known cardiovascular disease, (2) those with low-density lipoprotein cholesterol (LDL-C) levels 190 mg/dl or above, (3) diabetics with LDL-C levels 70-189 mg/dl, and (4) those with an estimated 10-year atherosclerotic cardiovascular disease risk score of 7.5% or more.
Unfortunately, some individuals are still at risk of sustaining MI despite the fact that they do not fit into one of these four high risk groups eligible for statins.
StainEPIC will enroll consecutive patients admitted with MI who are not on statins to examine their eligibility for these medications based on the AHA/ACC guidelines.
- Conditions
- Statins, Myocardial Infarction
- Being tested
- No intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention. Collection of data on statin eligibility in patients admitted with MI
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligible patients for statin therapy
The primary outcome is to calculate the percentage of enrolled patients who do meet the AHA/ACC Guidelines for receiving statins as a primary prevention measure.
Measured: Within 24 hour of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start22 Apr 2019
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Why it stopped: We recruited a target number (740 patients) earlier than the expected day of copletion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StatinsStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasmine Obeidat, MS, Study director, Hashemmeyyeh University School of Medicine, Zarka, JordanAyman J Hammoudeh, MD, FACC, Principal investigator, Istishari Hospital, Department of Cardiology, Amman, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485742
- Sponsor's protocol ID
- JCCStatinEpic2018
- Acronym
- StatinEPIC
- Status last verified
- Jun 2019
- First submitted
- 17 Mar 2018
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD files will be available for all study researchers: clinical data, lipid profile data, 10 year risk score data, statin eligibility data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Eligibility Prior to Myocardial InfarCtion in Jordanians
- ClinicalTrials.gov ID
- NCT03485742
- Acronym / sponsor ID
- StatinEPIC / JCCStatinEpic2018
- Conditions
- Statins, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We recruited a target number (740 patients) earlier than the expected day of copletion
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 2 Apr 2018 (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.
The study (Statin Eligibility Prior to myocardial infarction (MI) in Jordanians, StatinEPIC) is
- Cross sectional
- Non interventional
- One encounter per patient. No follow up. It addresses a major issue of primary prevention in Jordanians especially the young population, namely the issue of lipid lowering agents before sustaining an acute MI. A recent study in USA showed that 50% of patients who sustained MI were not eligible to statins had they been evaluated before the heart attack. It is largely unknown if a larger percentage of Middle Eastern patients who sustain a heart attack would be eligible to receive lipid lowering agents.
- The PI will overlook the whole process. Dr Ahmad Tamari, the assistant to the PI will asses this whole process of data collection, management and manuscript drafting.
Detailed description
Statins, when use as primary cardiovascular prevention strategy, have been shown to lower future acute cardiovascular events, especially myocardial infarction. However the use of statins in this context (i.e., primary prevention) is governed by guidelines that limit the use of statins to four high risk populations: (1) hose with known cardiovascular disease, (2) those with low-density lipoprotein cholesterol (LDL-C) levels 190 mg/dl or above, (3) diabetics with LDL-C levels 70-189 mg/dl, and (4) those with an estimated 10-year atherosclerotic cardiovascular disease risk score of 7.5% or more.
Unfortunately, some individuals are still at risk of sustaining MI despite the fact that they do not fit into one of these four high risk groups eligible for statins.
StainEPIC will enroll consecutive patients admitted with MI who are not on statins to examine their eligibility for these medications based on the AHA/ACC guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 30 to 75 years admitted with MI (ST elevation and non ST elevation) who are not receiving statins prior to admission will be evaluated for potential eligibility had they been evaluated prior to admission with MI.
Key inclusion criteria (2 listed)
- Adults admitted with MI, age 30 to 75
- known lipid profile
Key exclusion criteria (1 listed)
- on statin before enrollment
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 |
|---|---|---|
| No interventionNo intervention. Collection of data on statin eligibility in patients admitted with MI | Other | – |
Primary outcome
Eligible patients for statin therapy
Time frame: Within 24 hour of enrollment
The primary outcome is to calculate the percentage of enrolled patients who do meet the AHA/ACC Guidelines for receiving statins as a primary prevention measure.
Results and safety
The study was stopped early (reason given: We recruited a target number (740 patients) earlier than the expected day of copletion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: No. All IPD files will be available for all study researchers: clinical data, lipid profile data, 10 year risk score data, statin eligibility data.
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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.
Yasmine Obeidat, MS study director
Hashemmeyyeh University School of Medicine, Zarka, Jordan
Ayman J Hammoudeh, MD, FACC principal investigator
Istishari Hospital, Department of Cardiology, Amman, Jordan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Statins and Myocardial Infarction, run by Jordan Collaborating Cardiology Group at 5 sites in Jordan.
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 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: stopped early, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Jordan. 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 was stopped early (reason given: We recruited a target number (740 patients) earlier than the expected day of copletion). Results are not available in the source record.
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?
Eligible patients for statin therapy (time frame: Within 24 hour of enrollment). 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 26 Jun 2019.