- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05943821
The Effect of Allopurinol on the Risk of Cardiovascular Events in Patients With Cardiovascular Risk (ALL-VASCOR)
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of Allopurinol on the Risk of Cardiovascular Events in Patients With High and Very High Cardiovascular Risk, Including the Presence of Long-COVID Syndrome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Paweł Uruski, MD PhD
- Phone Number: 0048618546274
- Email: puruski@ump.edu.pl
Study Locations
-
-
Wielkopolska
-
Poznan, Wielkopolska, Poland, 60-355
- Recruiting
- Poznan University of Medical Sciences
-
Contact:
- Paweł Uruski, MD PhD
- Phone Number: 0048618546274
- Email: puruski@ump.edu.pl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: between 40-70 years old.
- Giving informed consent to participate in the study.
- Serum UA levels above 5 mg/dl within the last six months before the screening visit.
Meeting at least one of the criteria defining high or very high CV risk includes:
- calculated 10-year cardiovascular mortality risk based on SCORE2 >2.5% for patients under 50 years old or ≥5% for patients 50 years old or older
- documented occurrence of CV diseases (cerebrovascular disease: ischemic stroke, intracerebral bleeding, TIA; heart failure regardless of the etiology NYHA I - II (without IHD), PAD, atrial fibrillation (de novo or ever)
diabetes or arterial hypertension complicated by organ damage:
- increase in vascular stiffness: pulse pressure ≥ 60 mmHg, and/or cervicofemoral PWV > 10 m/s;
- features of left ventricular hypertrophy on echocardiography or electrocardiography;
- increased urine albumin-creatinine ratio (30-300 mg/g);
- ankle-brachial index < 0.9.
Exclusion Criteria:
- Taking allopurinol, febuxostat or other hypouricemic drugs.
- Contraindications to taking allopurinol.
- Pregnant women, breastfeeding or planning pregnancy during the duration of the study.
- Hormonal therapy containing oestrogens.
- Active cancer process or disease in the last five years, excluding locally malignant tumours.
- Uncontrolled hypertension (mean value ≥ 180/110 mmHg seven days before screening visit) in home measurements despite using hypotensive drugs.
- 7. Renal insufficiency with an eGFR <45 ml/ min/1.73m2 (according to 2009 CKD-EPI recommendations: stage G3b, G4 and G5).
- Hypothyroidism or hyperthyroidism not in a state of euthyroidism.
- Confirmed coronary artery disease (defined as prior AMI, revascularization of the myocardium, confirmed presence of atherosclerotic plaques in coronary arteries on imaging studies).
- Heart failure in NYHA class III and IV.
- Taking preparations: azathioprine, mercaptopurine or cyclosporin. Participation in another clinical trial of a medicinal product or medical device within the last three months or five half-lives, whichever period is longer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Allopurinol
The patients will receive allopurinol at an initial daily dose of 200 mg.
If insufficient therapy efficacy is noted, the initial allopurinol dose will be increased by 100 mg (up to 300 mg during V2).
Similarly, the dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).
|
The intervention will occur after randomly allocating participants to the first group (G1), in which patients will receive allopurinol at an initial daily dose of 200 mg, or to the second group (G2), where they will receive a placebo.
The placebo will be prepared as tablets with the same shape and appearance as the tested drug tablets, in the appropriate doses, and containing the same excipients.
Participants will initially take one tablet of the medication daily in the morning.
The physicians will dispense the drugs in packs of 30 tablets for the entire interval between visits (therapy 26 weeks ± 2 weeks).
The patients will receive the medications during visit V1.
The drugs will be prepared in identical packages, appropriately sealed, with a number for drug identification.
Other Names:
Approximately 26 weeks(+/-2 weeks) after the start of the intervention, the efficacy of the treatment will be evaluated at the follow-up visit V2. Efficacy is defined as achieving a serum UA level below 5.0mg/dL for those with baseline levels >5.0 to 7.0mg/dL or below 5.5mg/dL for those with baseline levels ≥7.0mg/dL. If insufficient therapy efficacy is noted, the initial allopurinol dose will be increased by 100mg (up to 300mg during V2). The dose may be increased by another 100mg at visit 3 and by another 100mg at the visit 4(up to 500mg during V4). In the placebo group, an appropriate preparation will be added so that the number of tablets corresponds to the group with the active substance. This treatment will be continued until the end of the bservation. Patients who meet their UA target concentration at visit V2 or V3, or V4, and those who fail to meet their target concentration at visit V4, will not have their dosing changed until the end of the follow-up.
Other Names:
|
Placebo Comparator: Placebo
The patients will receive placebo at an initial daily dose of 200 mg.
The dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).
|
The intervention will occur after randomly allocating participants to the first group (G1), in which patients will receive allopurinol at an initial daily dose of 200 mg, or to the second group (G2), where they will receive a placebo.
The placebo will be prepared as tablets with the same shape and appearance as the tested drug tablets, in the appropriate doses, and containing the same excipients.
Participants will initially take one tablet of the medication daily in the morning.
The physicians will dispense the drugs in packs of 30 tablets for the entire interval between visits (therapy 26 weeks ± 2 weeks).
The patients will receive the medications during visit V1.
The drugs will be prepared in identical packages, appropriately sealed, with a number for drug identification.
Other Names:
Approximately 26 weeks(+/-2 weeks) after the start of the intervention, the efficacy of the treatment will be evaluated at the follow-up visit V2. Efficacy is defined as achieving a serum UA level below 5.0mg/dL for those with baseline levels >5.0 to 7.0mg/dL or below 5.5mg/dL for those with baseline levels ≥7.0mg/dL. If insufficient therapy efficacy is noted, the initial allopurinol dose will be increased by 100mg (up to 300mg during V2). The dose may be increased by another 100mg at visit 3 and by another 100mg at the visit 4(up to 500mg during V4). In the placebo group, an appropriate preparation will be added so that the number of tablets corresponds to the group with the active substance. This treatment will be continued until the end of the bservation. Patients who meet their UA target concentration at visit V2 or V3, or V4, and those who fail to meet their target concentration at visit V4, will not have their dosing changed until the end of the follow-up.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The occurrence of a major adverse cardiovascular event (MACE)
Time Frame: Baseline up to approximately 5 years
|
The number of all causes of death, cardiac death, stroke, transient ischemic attack, acute coronary syndrome, coronary angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina or worsening heart failure
|
Baseline up to approximately 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants of all-cause death
Time Frame: Baseline up to approximately 5 years
|
Events were adjudicated by researchers as all-cause death.
The number of all-cause deaths recorded from visit 0 (screening visit) to the last follow-up visit.
Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11.
|
Baseline up to approximately 5 years
|
Percentage of Participants With Cardiac Death
Time Frame: Baseline up to approximately 5 years
|
Description:Events were adjudicated by researchers as cardiac death.
The number of all-cause deaths recorded from visit 0 (screening visit) to the last follow-up visit.
Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11.
|
Baseline up to approximately 5 years
|
Percentage of Participants With stroke
Time Frame: Baseline up to approximately 5 years
|
Description:Events were adjudicated by researchers as stroke.
The number of all-stroke recorded from visit 0 (screening visit) to the last follow-up visit.
Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
|
Baseline up to approximately 5 years
|
Percentage of Participants With transient ischemic attack
Time Frame: Baseline up to approximately 5 years
|
Description:Events were adjudicated by researchers as transient ischemic attack.
The number of transient ischemic attack recorded from visit 0 (screening visit) to the last follow-up visit.
Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
|
Baseline up to approximately 5 years
|
Percentage of Participants With acute coronary syndrome
Time Frame: Baseline up to approximately 5 years
|
Description:Events were adjudicated by researchers as acute coronary syndrome,.
The number of acute coronary syndrome, recorded from visit 0 (screening visit) to the last follow-up visit.
Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
|
Baseline up to approximately 5 years
|
Percentage of Participants With coronary angioplasty or revascularization
Time Frame: Baseline up to approximately 5 years
|
Description:Events were adjudicated by researchers as coronary angioplasty or revascularization.
The number of coronary angioplasty or revascularization, recorded from visit 0 (screening visit) to the last follow-up visit.
Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
|
Baseline up to approximately 5 years
|
Percentage of Participants With peripheral arterial angioplasty
Time Frame: Baseline up to approximately 5 years
|
Description:Events were adjudicated by researchers as peripheral arterial angioplasty.
The number of peripheral arterial angioplasty recorded from visit 0 (screening visit) to the last follow-up visit.
Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
|
Baseline up to approximately 5 years
|
Percentage of Participants With hospitalization for unstable angina or worsening heart failure
Time Frame: Baseline up to approximately 5 years
|
Events were adjudicated by researchers as endpoint hospitalization (hospitalization and stay in the emergency department due to heart failure, need for intravenous loop diuretics and/or doubling the dose of oral loop diuretics). The number of hospitalization for unstable angina or worsening heart failure recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11 |
Baseline up to approximately 5 years
|
Percentage of Participants With Hospitalization
Time Frame: Baseline up to approximately 5 years
|
Events were adjudicated by researchers as endpoint hospitalization.
The number of hospitalization for reasons other than the endpoint number 9, recorded from visit 0 (screening visit) to the last follow-up visit.
Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
|
Baseline up to approximately 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of progression and/or development of organ complications and atherosclerosis, including: echocardiography
Time Frame: Baseline up to the follow-up visit number 7 - approximately 3 years
|
assessment of echocardiographic parameters - analysis of changes in echocardiographic parameters assessed in transthoracic echocardiographic examination (TTE).Assessment of systolic function (ejection fraction) and left ventricular hypertrophy.
Analysis of changes from the baseline
|
Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assessment of progression and/or development of organ complications and atherosclerosis, including the assessment of incidence of atrial fibrillation
Time Frame: Baseline up to the follow-up visit number 7 - approximately 3 years
|
the assessment of the incidence of atrial fibrillation in an electrocardiographic examination (documented incident of de novo atrial fibrillation during observation)
|
Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assessment of progression and/or development of organ complications and atherosclerosis, including the assessment of end-stage kidney disease
Time Frame: Baseline up to the follow-up visit number 7 - approximately 3 years
|
the assessment of end-stage kidney disease based on eGFR measurements.
Analysis of changes from the baseline
|
Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assessment of progression and/or development of organ complications and atherosclerosis, including Ultrasound examination
Time Frame: Baseline up to the follow-up visit number 7 - approximately 3 years
|
The assessment of abdominal aorta diameter.
Analysis of changes from the baseline
|
Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assessment of progression and/or development of organ complications and atherosclerosis, including Doppler ultrasound of carotid arteries
Time Frame: Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assessment of intima-media complex and atherosclerotic plaques.
Analysis of changes from the baseline
|
Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assessment of progression and/or development of organ complications and atherosclerosis, including the assessment of ankle-brachial index
Time Frame: Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assessment of ankle-brachial index.
Analysis of changes from the baseline
|
Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assessment of progression and/or development of organ complications and atherosclerosis, including the assessment of pulse wave velocity
Time Frame: Baseline up to the follow-up visit number 7 - approximately 3 years
|
the assessment of pulse wave velocity.
Analysis of changes from the baseline
|
Baseline up to the follow-up visit number 7 - approximately 3 years
|
Occurrence of long-COVID symptoms
Time Frame: Baseline up to approximately 5 years
|
Occurrence of long-COVID symptoms assessed based on a survey.
Analysis of changes from the baseline.
The survey will be recorded from visit 0 (screening visit) to the last follow-up visit.
Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
|
Baseline up to approximately 5 years
|
The assessment of treatment efficacy
Time Frame: Baseline up to the follow-up visit number 7- approximately 3 years
|
Attainment of target serum UA levels of 5 mg/dL or 5.5 mg/dL, depending on baseline values
|
Baseline up to the follow-up visit number 7- approximately 3 years
|
Assessment of the laboratory parameters
Time Frame: Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assesment of: Estimated glomerular filtration rate (eGFR). Albumin to creatinine ratio and urinary albuminuria. Glycosylated hemoglobin (HbA1c). Lipid profile. Plasma C-reactive protein concentrations. Activity of aspartate and alanine transaminases (AST, ALT) Analysis all parameters of changes from the baseline |
Baseline up to the follow-up visit number 7 - approximately 3 years
|
Assessment of frequency of side effects
Time Frame: From the first dose of allopurinol or placebo until the end of the observation period (approximately 3-5 years)
|
Proportion of subjects who experienced at least one serious adverse event (SAE) during the study
|
From the first dose of allopurinol or placebo until the end of the observation period (approximately 3-5 years)
|
Assessment of changes in participants' cardiovascular risk
Time Frame: Baseline up to approximately 5 years
|
Assessment of changes in participants' cardiovascular risk based on the SCORE 2 scale.
Analysis of changes from the baseline
|
Baseline up to approximately 5 years
|
Collaborators and Investigators
Investigators
- Study Director: Andrzej Tykarski, Prof MD, Poznan University of Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/ABM/01/00027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinRecruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
Clinical Trials on Allopurinol 200 mg
-
Ardea Biosciences, Inc.Completed
-
Ardea Biosciences, Inc.Completed
-
Ardea Biosciences, Inc.Completed
-
Yuhan CorporationCompleted
-
Mylan Pharmaceuticals IncCompletedHealthyUnited States
-
Novartis PharmaceuticalsRecruitingNon-Small Cell Lung CarcinomaIndia
-
AstraZenecaCompletedHeart Failure With Preserved Ejection Fraction (HFpEF)United States, Germany, Canada, Korea, Republic of, Austria, Slovakia, Australia, Bulgaria, Russian Federation, Argentina, Poland, Mexico
-
Ardea Biosciences, Inc.Quotient ClinicalCompleted
-
Atabay Kimya Sanayi Ticaret A.S.Novagenix Bioanalytical Drug R&D Center; Farmagen Ar-Ge Biyot. Ltd. StiCompleted