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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03485742
Other study ID # JCCStatinEpic2018
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 22, 2019
Est. completion date June 10, 2019

Study information

Verified date June 2019
Source Jordan Collaborating Cardiology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

4. 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 740
Est. completion date June 10, 2019
Est. primary completion date June 10, 2019
Accepts healthy volunteers
Gender All
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria:

- Adults admitted with MI, age 30 to 75

- known lipid profile

Exclusion Criteria:

- on statin before enrollment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention. Collection of data on statin eligibility in patients admitted with MI

Locations

Country Name City State
Jordan Istishari Hospital Amman
Jordan Jordan Hospital Amman
Jordan Khalidi Hospital & Medical Center Amman
Jordan The University of Jordan Amman
Jordan King Abdullah University Hospital Irbid

Sponsors (1)

Lead Sponsor Collaborator
Jordan Collaborating Cardiology Group

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 24 hour of enrollment
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