Tracking of Lipid Lowering Therapy in Jordan

NCT05629767 | Terminated

• 1 other identifier: JCCG.JoLLA.10.2022
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

The present study aims to examine the clinical practice of modifying the dose of lipid-lowering therapy in patients with atherosclerotic cardiovascular disease (ASCVD), who have LDL-C \> 70 mg/dl despite statin treatment.

Conditions

Dyslipidemias; Atherosclerotic Cardiovascular Disease

Keywords

Low-density lipoprotein cholesterol (LDL-C), Target levels

Outcome Measures

Primary Outcomes (3)

• Achieving a target LDL-C bloob level of 70 mg/dl or less

  At 1 year of follow up, all participants will have their blood lipid profile measured to examine the frequency of attaining an LDL-C level of 70 mg/dl or less

  12 months

• Modifying the dose and class of lipid-lowering therapy

  Up titrating the dose of the same lipid-lowering agent or adding new agent during the study period of 12 months. Agents available include statins, ezetimibe and PCSK9 inhibitors.

  12 months

• Clinical cardiovascular events

  The study will study the frequency of incident acute cardiovascular the participating individuals experienced. Such events include cardiovascular death, acute coronary syndrome, stroke, lower extremity acute arterial insufficiency, and arterial revascularization procedure (coronary and other arterial beds).

  12 months

Study Arms (1)

Patients with ASCVD

Patients with ASCVD on statins and LDL-C more than 70 mg/dl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll adults aged 18 years or old with a diagnosis of atherosclerotic cardiovascular disease on lipid-lowering therapy (statins and non-statins) and an LDL-C \> 70mg/dl. and follow them up for 12 months to evaluate the up-titrating of the lipid-lowering therapy and the frequency of repeating the lipid measurement.

You may qualify if:

• Adults aged 18 years or old.
• Presence of atherosclerotic cardiovascular disease on lipid-lowering therapy.
• LDL-C \> 70mg/dl.
• Willingness to sign an informed consent.

You may not qualify if:

• Life-threatening disease with limited survival.
• Unwillingness to sign an informed consent.

Sponsors & Collaborators

• Jordan Collaborating Cardiology Group: lead

Study Sites (2)

Istishari Hospital

Amman, 11184, Jordan

Location

Abdali Hospital

Amman, Jordan

Location

Related Publications (5)

• Shi A, Tao Z, Wei P, Zhao J. Epidemiological aspects of heart diseases. Exp Ther Med. 2016 Sep;12(3):1645-1650. doi: 10.3892/etm.2016.3541. Epub 2016 Jul 26.

  PMID: 27602082 RESULT

• Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.

  PMID: 24239923 RESULT

• Wilson PWF, Polonsky TS, Miedema MD, Khera A, Kosinski AS, Kuvin JT. Systematic Review for the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):3210-3227. doi: 10.1016/j.jacc.2018.11.004. Epub 2018 Nov 10.

  PMID: 30423394 RESULT

• Bloom BS. Effects of continuing medical education on improving physician clinical care and patient health: a review of systematic reviews. Int J Technol Assess Health Care. 2005 Summer;21(3):380-5. doi: 10.1017/s026646230505049x.

  PMID: 16110718 RESULT

• Santi RL, Martinez F, Baranchuk A, Liprandi AS, Piskorz D, Lorenzatti A, Santi MPL, Kaski JC. Management of Dyslipidaemia in Real-world Clinical Practice: Rationale and Design of the VIPFARMA ISCP Project. Eur Cardiol. 2021 Apr 27;16:e16. doi: 10.15420/ecr.2020.42. eCollection 2021 Feb.

  PMID: 33995586 RESULT

MeSH Terms

Conditions

Dyslipidemias; Atherosclerosis

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ayman Hammoudeh, MD FACC

  Istishari Hospital, Amman, Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2022
• First Posted: November 29, 2022
• Study Start: December 11, 2022
• Primary Completion: December 13, 2023
• Study Completion: January 2, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

JO (2)