Clinical trial NCT05629767: Tracking of Lipid Lowering Therapy in Jordan
Official title: Tracking Lipid-Lowering Therapy Over One Year in Middle Eastern Patients With ASCVD. The Jordan LLA Tracking Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dyslipidemias
Atherosclerotic Cardiovascular Disease
Keywords: Low-density lipoprotein cholesterol (LDL-C), Target levels
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Achieving a target LDL-C bloob level of 70 mg/dl or less
timeFrame: 12 months
measure: Modifying the dose and class of lipid-lowering therapy
timeFrame: 12 months
measure: Clinical cardiovascular events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Istishari Hospital
city: Amman
country: Jordan
facility: Abdali Hospital
Study officials:
affiliation: Istishari Hospital, Amman, Jordan
name: Ayman Hammoudeh, MD FACC
role: PRINCIPAL_INVESTIGATOR
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