Statin Intolerance in Patients With Myocardial Infarction NCT04069598

Updated 06/21/2024

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT04069598
Other study ID #	A-HIT 4-SI Study
Secondary ID
Status	Recruiting
Phase
First received
Last updated
Start date	August 26, 2019
Est. completion date	March 31, 2020

Study information
Verified date	September 2019
Source	Turkish Society of Cardiology
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

Patients with acute coronary syndrome (MI, NSTEMI, USAP) will be included. They will be screened for statin intolernace for 6 months.

Recruitment information / eligibility
Status	Recruiting
Enrollment	600
Est. completion date	March 31, 2020
Est. primary completion date	March 2, 2020
Accepts healthy volunteers
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Acute coronary syndrome Exclusion Criteria: - Being on statin, having statin related side effects

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Statin intolerance test
Statin intolerance test

Locations
Country	Name	City	State
Turkey	Haseki	Istanbul
Turkey	Siyami Ersek	Istanbul
Turkey	Tepecik	Izmir
Turkey	Ozcan Basaran	Mugla

Sponsors *(1)*
Lead Sponsor	Collaborator
Turkish Society of Cardiology

Country where clinical trial is conducted

Turkey,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Statin intolerance	Number (percentage) of patients with statin intolerance	6 months

See also
	Status	Clinical Trial	Phase
	Completed	`NCT04986241` - The Association of Statins on Cardiorespiratory Fitness and Exercise Adaptation
	Recruiting	`NCT04499859` - Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI	Phase 4
	Completed	`NCT03001076` - Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)	Phase 3
	Completed	`NCT02988115` - Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant	Phase 3
	Recruiting	`NCT05332158` - Medicines Gaps Study	N/A
	Not yet recruiting	`NCT06381947` - Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients	Phase 4
	Completed	`NCT03874156` - MUscle Side-Effects of Atorvastatin in Coronary Patients	Phase 4
	Not yet recruiting	`NCT06262685` - Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins	Phase 4
	Completed	`NCT05806723` - Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men	Phase 4
	Active, not recruiting	`NCT03653663` - NIRS to Diagnose SAMS	Phase 4
	Completed	`NCT02993406` - Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo	Phase 3
	Completed	`NCT04453735` - MUscle Side-Effects of Atorvastatin in Coronary Patients (MUSE) -Follow-up Study	Phase 4
	Terminated	`NCT04507373` - 7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events	Phase 4