Tracking of Lipid Lowering Therapy in Jordan

Dyslipidemias Clinical Trial

— JoLLA  

Official title:

Tracking Lipid-Lowering Therapy Over One Year in Middle Eastern Patients With ASCVD. The Jordan LLA Tracking Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05629767
• Other study ID #: JCCG.JoLLA.10.2022
• Status: Terminated
• Start date: December 11, 2022
• Est. completion date: January 2, 2024

Study information

• Verified date: February 2024
• Source: Jordan Collaborating Cardiology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

ASCVD is the leading cause of morbidity and mortality worldwide, in the Middle East and in Jordan. One of the major risk factors that contribute to the development and progression of ASCAD is dyslipidemia. A large number of clinical trials have reported the benefits of lowering LDL-C, in reducing the mortality rate among ASCAD patients.

The 2019 ACC/AHA blood cholesterol treatment guideline to reduce atherosclerotic cardiovascular risk in adults has expanded the role of LDL-C targets and reiterated the importance of achieving an LDL-C level of 70 mg/dl or less for patients who have ASCVD.

Patients on statins and other lipid-lowering therapy in Jordan have not been tracked in the past for the potential of up escalating the lipid-lowering therapy to reach the LDL-C target.

The investigation will enroll patients with ASCVD who have LAL-C >70 mg/dl on lipid-lowering therapy and follow them for 12 months to examine the treating physicians' action in up-titrating the lipid-lowering therapy dose(s) and the frequency of measuring serum lipids during the study period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: January 2, 2024
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Adults aged 18 years or old.

2. Presence of atherosclerotic cardiovascular disease on lipid-lowering therapy.

3. LDL-C > 70mg/dl.

4. Willingness to sign an informed consent.

Exclusion criteria

1. Life-threatening disease with limited survival.

2. Unwillingness to sign an informed consent.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Dyslipidemias

Locations

Country	Name	City	State
Jordan	Abdali Hospital	Amman
Jordan	Istishari Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Jordan Collaborating Cardiology Group

Country where clinical trial is conducted

Jordan, 

References & Publications (5)

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. — View Citation

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/ec — View Citation

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. — View Citation

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 Fo — View Citation

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/Am — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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