Cardiovascular DiseasesPhase 3ALL-VASCORNCT05943821

The Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with Cardiovascular Risk

A Phase 3 study testing Allopurinol 200 mg and Optional intervention in people with Cardiovascular Diseases and Uric Acid, run by Poznan University of Medical Sciences at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Numerous studies, but not all, have suggested a positive effect of allopurinol on the cardiovascular system. The ALL-VASCOR study aims to evaluate the efficacy of allopurinol therapy for improving cardiovascular outcomes in patients at high and very high cardiovascular risk, excluding ischemic heart disease. Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Cardiovascular Diseases, Uric Acid
What is being tested?: Allopurinol 200 mg and Optional intervention
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,116 participants
Where: 1 sitePoland
Study dates: 1 Sep 2023to 31 Jul 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paweł Uruski, MD PhD contact

0048618546274

puruski@ump.edu.pl

Poland1 site, 1 recruiting

Poznan University of Medical Sciences
Poznan, Wielkopolska, 60-355
Paweł Uruski, MD PhD, 0048618546274, puruski@ump.edu.pl
Recruiting

Other trials in Poland

About this study

Official title: 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.

Read the detailed description

The ALL-VASCOR study is a randomized, double-blind, placebo-controlled, multi-center trial that examines the effect of allopurinol therapy (200-500mg of allopurinol daily) versus an equivalent dose of placebo on the risk of cardiovascular events in 1,116 patients aged 40-70, with serum uric acid levels above 5mg/dL and with high and very high risk for cardiovascular disease. The ALL-VASCOR study is further designed to assess the occurrence of long-COVID syndrome. The study is directed toward both primary and secondary as well as additional endpoints. Due to the duration of the study, the planned intervention will end on July 31,2028, unless the Safe Monitoring Board or other applicable authorities decide about it. Participant recruitment for the ALL-VASCOR study is set to begin in August of 2023 and will be conducted only within Poland.

Conditions: Cardiovascular Diseases, Uric Acid
Being tested: Allopurinol 200 mg, Optional intervention
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Allopurinol 200 mgDrug
Also called Allopurinol
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.
Optional interventionDrug
Also called Please describe in more detail
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.

Study groups in NCT05943821
Study group	Role	What they receive
Allopurinol	Active comparator	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). Receives: Drug: Allopurinol 200 mg; Drug: Optional intervention
Placebo	Placebo comparator	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). Receives: Drug: Allopurinol 200 mg; Drug: Optional intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

The occurrence of a major adverse cardiovascular event (MACE)
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
Measured: Baseline up to approximately 5 years

Secondary outcomes (9)

Percentage of Participants of all-cause death
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.
Measured: Baseline up to approximately 5 years
Percentage of Participants With Cardiac Death
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.
Measured: Baseline up to approximately 5 years
Percentage of Participants With stroke
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
Measured: Baseline up to approximately 5 years
Percentage of Participants With transient ischemic attack
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
Measured: Baseline up to approximately 5 years
Percentage of Participants With acute coronary syndrome
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
Measured: Baseline up to approximately 5 years
Percentage of Participants With coronary angioplasty or revascularization
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
Measured: Baseline up to approximately 5 years
Percentage of Participants With peripheral arterial angioplasty
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
Measured: Baseline up to approximately 5 years
Percentage of Participants With hospitalization for unstable angina or worsening heart failure
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
Measured: Baseline up to approximately 5 years
Percentage of Participants With Hospitalization
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
Measured: Baseline up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202331 Jul 2028

First posted13 Jul 2023
Study start1 Sep 2023
Primary completion31 Jul 2028 (estimated)
Study completion31 Jul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,116 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05943821
Sponsor's protocol ID: 2022/ABM/01/00027
Acronym: ALL-VASCOR
Status last verified: Jan 2025
First submitted: 5 Jul 2023
Last updated: 6 Jan 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lewandowska K, Lipski D, Uruski P, Narkiewicz K, Januszewicz A, Wolf J, Prejbisz A, Rajzer M, Wiecek A, Tykarski A. Randomised, 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-19 syndrome: the ALL-VASCOR study protocol. BMJ Open. 2024 Jul 24;14(7):e075741. doi: 10.1136/bmjopen-2023-075741.
PubMed 39053954

Interested in taking part?

Paweł Uruski, MD PhD

0048618546274

puruski@ump.edu.pl

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT05943821
Acronym / sponsor ID: ALL-VASCOR / 2022/ABM/01/00027
Conditions: Cardiovascular Diseases, Uric Acid
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,116 participants (estimated)
Lead sponsor: Poznan University of Medical SciencesUniversity, hospital or other
Study start: 1 Sep 2023 (actual)
Primary completion: 31 Jul 2028 (estimated)
Study completion: 31 Jul 2028 (estimated)
First posted: 13 Jul 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Allopurinol	Active comparator	Drug: Allopurinol 200 mg, Drug: Optional interventionThe 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).
Placebo	Placebo comparator	Drug: Allopurinol 200 mg, Drug: Optional interventionThe 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).

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Allopurinol 200 mgAlso: AllopurinolThe 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.	Drug	Allopurinol, Placebo
Optional interventionAlso: Please describe in more detailApproximately 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.	Drug	Allopurinol, Placebo

Primary outcome

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

9 secondary outcomes

Percentage of Participants of all-cause death
Time frame: Baseline up to approximately 5 years
Percentage of Participants With Cardiac Death
Time frame: Baseline up to approximately 5 years
Percentage of Participants With stroke
Time frame: Baseline up to approximately 5 years
Percentage of Participants With transient ischemic attack
Time frame: Baseline up to approximately 5 years
Percentage of Participants With acute coronary syndrome
Time frame: Baseline up to approximately 5 years
Percentage of Participants With coronary angioplasty or revascularization
Time frame: Baseline up to approximately 5 years
Percentage of Participants With peripheral arterial angioplasty
Time frame: 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
Percentage of Participants With Hospitalization
Time frame: Baseline up to approximately 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
Derived from this study: PubMed 39053954Lewandowska K, Lipski D, Uruski P, Narkiewicz K, Januszewicz A, Wolf J, Prejbisz A, Rajzer M, Wiecek A, Tykarski A. Randomised, 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-19 syndrome: the ALL-VASCOR study protocol. BMJ Open. 2024 Jul 24;14(7):e075741. doi: 10.1136/bmjopen-2023-075741.
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.

Paweł Uruski, MD PhD contact

0048618546274

puruski@ump.edu.pl

Andrzej Tykarski, Prof MD study director

Poznan University of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Allopurinol 200 mg and Optional intervention in people with Cardiovascular Diseases and Uric Acid, run by Poznan University of Medical Sciences at 1 site in Poland.

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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paweł Uruski, MD PhD (0048618546274, puruski@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of a major adverse cardiovascular event (MACE) (time frame: Baseline up to approximately 5 years). 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 NCT05943821, which also lists 1 linked publication.

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 6 Jan 2025.