JoLLA: Tracking of Lipid Lowering Therapy in Jordan

Sponsor
Jordan Collaborating Cardiology Group (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05629767
Collaborator
(none)
1,000
2
18.7
500
26.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Tracking Lipid-Lowering Therapy Over One Year in Middle Eastern Patients With ASCVD. The Jordan LLA Tracking Study
    Anticipated Study Start Date :
    Dec 11, 2022
    Anticipated Primary Completion Date :
    Dec 13, 2023
    Anticipated Study Completion Date :
    Jul 2, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with ASCVD

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

    Outcome Measures

    Primary Outcome Measures

    1. Achieving a target LDL-C bloob level of 70 mg/dl or less [12 months]

      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

    2. Modifying the dose and class of lipid-lowering therapy [12 months]

      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.

    3. Clinical cardiovascular events [12 months]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istishari Hospital Amman Jordan 11184
    2 Abdali Hospital Amman Jordan

    Sponsors and Collaborators

    • Jordan Collaborating Cardiology Group

    Investigators

    • Principal Investigator: Ayman Hammoudeh, MD FACC, Istishari Hospital, Amman, Jordan

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Jordan Collaborating Cardiology Group
    ClinicalTrials.gov Identifier:
    NCT05629767
    Other Study ID Numbers:
    • JCCG.JoLLA.10.2022
    First Posted:
    Nov 29, 2022
    Last Update Posted:
    Nov 29, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jordan Collaborating Cardiology Group
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 29, 2022