DyslipidemiasJoLLANCT05629767
Tracking of Lipid Lowering Therapy in Jordan
An observational study of Dyslipidemias and Atherosclerotic Cardiovascular Disease, run by Jordan Collaborating Cardiology Group at 2 sites in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemias, Atherosclerotic Cardiovascular Disease
- How many people
- 1,000 participants
- Where
- 2 sitesJordan
- Study dates
- 11 Dec 2022to 2 Jan 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Life-threatening disease with limited survival.
- Unwillingness to sign an informed consent.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Tracking Lipid-Lowering Therapy Over One Year in Middle Eastern Patients With ASCVD. The Jordan LLA Tracking Study
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.
Read the 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.
- Keywords
- Low-density lipoprotein cholesterol (LDL-C), Target levels
- Medical subject headings
- Dyslipidemias, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ASCVD | Patients with ASCVD on statins and LDL-C more than 70 mg/dl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start11 Dec 2022
- Primary completion13 Dec 2023
- Study completion2 Jan 2024
Why it stopped: Inadequate enrolling numbers of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayman Hammoudeh, MD FACC, Principal investigator, Istishari Hospital, Amman, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629767
- Sponsor's protocol ID
- JCCG.JoLLA.10.2022
- Acronym
- JoLLA
- Status last verified
- Feb 2024
- First submitted
- 29 Oct 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27602082Stone 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.
PubMed 24239923Wilson 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.
PubMed 30423394Bloom 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.
PubMed 16110718Santi 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.
PubMed 33995586
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Lipid-Lowering Therapy Over One Year in Middle Eastern Patients With ASCVD. The Jordan LLA Tracking Study
- ClinicalTrials.gov ID
- NCT05629767
- Acronym / sponsor ID
- JoLLA / JCCG.JoLLA.10.2022
- Keywords
- Low-density lipoprotein cholesterol (LDL-C), Target levels
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate enrolling numbers of patients
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 11 Dec 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ASCVD | – | –Patients with ASCVD on statins and LDL-C more than 70 mg/dl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Life-threatening disease with limited survival.
- Unwillingness to sign an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Achieving a target LDL-C bloob level of 70 mg/dl or less
Time frame: 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
Modifying the dose and class of lipid-lowering therapy
Time frame: 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.
Clinical cardiovascular events
Time frame: 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).
Results and safety
The study was stopped early (reason given: Inadequate enrolling numbers of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Results publication: PubMed 27602082Shi 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.
- Results publication: PubMed 24239923Stone 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.
- Results publication: PubMed 30423394Wilson 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.
- Results publication: PubMed 16110718Bloom 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.
- Results publication: PubMed 33995586Santi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Hammoudeh, MD FACC principal investigator
Istishari Hospital, Amman, Jordan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias and Atherosclerotic Cardiovascular Disease, run by Jordan Collaborating Cardiology Group at 2 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrolling numbers of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving a target LDL-C bloob level of 70 mg/dl or less (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05629767, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.