An interventional study of extended release dipyridamole 200mg/aspirin 25mg and 81mg aspirin in Systemic Lupus Erythematosus, sponsored by Oklahoma Medical Research Foundation. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-11-25.
Sponsored by Oklahoma Medical Research Foundation · Not applicable, Interventional, and Treatment
Among 10 studies in Lupus Erythematosus, Systemic by Oklahoma Medical Research Foundation — none open to participants now, none under way, none of them phase 3. Lupus Erythematosus, Systemic · Oklahoma Medical Research Foundation.
Among the 10 studies in Lupus Erythematosus, Systemic by Oklahoma Medical Research Foundation, this one is the only one that started in 2013, is the only one with no phase, and was the 6th registered.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's enrollment of 18 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →None of the 10 studies in Lupus Erythematosus, Systemic by Oklahoma Medical Research Foundation is open now.
Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 92 (32%) set no upper age limit and 162 (57%) stop at 75 or younger; 54 take children under 18; 34 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 1 started in 2013.
Median enrollment 20 across the 8 interventional studies, 2,908 across the 2 observational. Of the 8 that completed or were terminated, 4 (50%) have results posted.
Oklahoma Medical Research Foundation is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Lupus Erythematosus, Systemic by Oklahoma Medical Research Foundation, from their registry updates:
Nothing recorded among them since 2026-09-25.
Dipyridamole, a medication extensively used in combination with aspirin for stroke prevention, is a promising new treatment for lupus. Dipyridamole has been shown to inhibit certain lymphocyte populations that are over-reactive in lupus and to delay the emergence of lupus-related pathology in mice with lupus. The investigators are interested in investigating the efficacy of dipyridamole in preventing flares in patients with lupus and its impact on biomarkers of disease activity.
T cells in systemic lupus erythematosus (SLE) express an abnormal phenotype characterized by increased effector functions and deficient regulatory responses. Dipyridamole, a phosphodiesterase inhibitor extensively used in combination with low dose aspirin in secondary stroke prevention, has been proposed as a specific T cell directed treatment for SLE. Dipyridamole inhibits the calcium/calcineurin/NF-AT pathway in SLE T cells in vitro and abrogates expression of cytokines and costimulatory molecules, eventually also affecting B cell responses. Dipyridamole delays the emergence of lupus related pathology in lupus prone mice, but has not yet been studied in humans with SLE. The investigators aim to investigate the efficacy of dipyridamole in the prevention of flares in SLE patients after withdrawal of background immunosuppressive medications. The investigators will additionally evaluate the safety and tolerability of dipyridamole and its impact on quality of life measures in this population. Furthermore, the effect of dipyridamole on T and B cell biomarkers will be examined.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks
Drug: extended release dipyridamole 200mg/aspirin 25mg
half a tablet of a 81mg aspirin twice daily for 24 weeks
Drug: 81mg aspirin
one tablet twice daily for 24 weeks
Also known as: Aggrenox
half a tablet twice daily for 24 weeks
Also known as: ASA
British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA)
This is a landmark measure of percentage of patients who meet response criteria. To meet the BICLA response measure a patient must, compared to baseline, have a decrease in all moderate or severe scores on the British Isles Lupus Assessment Group (BILAG) index by at least one severity grade (Severe disease (BILAG A score) must drop to at least moderate (B or better) and B must drop to at least mild (C or not present). Also, there must be no increase in any other BILAG organ scores, no increase in The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, and no increase in the physician's global assessment (PGA) by more than 10% of the scale. Furthermore, there may no off protocol medication increases. Note on all scales mentioned a higher score signifies greater disease activity. Ranges on BILAG could be 0-108 but are rarely greater than 36. SLEDAI could range 0-105 but is rarely greater than 20. PGA 0-100 but rarely greater than 76.
Time frame: 24 weeks
Systemic Lupus Erythematosus Responder Index (SRI) 4
This is a landmark analysis of percentage of patients who meet the following response criteria: Compared to baseline there must be a 4 point decrease in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), no increase in The British Isles Lupus Assessment Group (BILAG) Index score and no more of an increase in Physician's Global Assessment (PGA) than 10% of the scale. As assessed here, there must also be no off protocol increase in medications. All scales signify worsening disease when scores increase. Ranges on BILAG could be 0-108 but are rarely greater than 36. SLEDAI could range 0-105 but is rarely greater than 20. PGA 0-100 but rarely greater than 76.
Time frame: 24 weeks
SRI Component Analyses: 4 Point Drop in SLEDAI
This is a landmark analysis of percentage of patients who, compared to baseline, have a 4 point drop in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). A 4 point decrease signifies a clinically significant decrease in disease activity as reported in many studies and as commonly used as a clinical endpoint in trials. SLEDAI could range 0-105 but is rarely greater than 20.
Time frame: 24 weeks
All patients were recruited from the Oklahoma Medical Research Foundation clinic after a full informed consent process.
| Milestone | Extended Release Dipyridamole/Aspirin | Aspirin |
|---|---|---|
| Started | 13 | 5 |
| Completed | 9 | 5 |
| Not completed | 4 | 0 |
| Withdrew: Adverse event | 4 | 0 |
This is a landmark measure of percentage of patients who meet response criteria. To meet the BICLA response measure a patient must, compared to baseline, have a decrease in all moderate or severe scores on the British Isles Lupus Assessment Group (BILAG) index by at least one severity grade (Severe disease (BILAG A score) must drop to at least moderate (B or better) and B must drop to at least mild (C or not present). Also, there must be no increase in any other BILAG organ scores, no increase in The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, and no increase in the physician's global assessment (PGA) by more than 10% of the scale. Furthermore, there may no off protocol medication increases. Note on all scales mentioned a higher score signifies greater disease activity. Ranges on BILAG could be 0-108 but are rarely greater than 36. SLEDAI could range 0-105 but is rarely greater than 20. PGA 0-100 but rarely greater than 76.
| Participants | Extended Release Dipyridamole/Aspirin | Aspirin |
|---|---|---|
| British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) | 3 | 2 |
This is a landmark analysis of percentage of patients who meet the following response criteria: Compared to baseline there must be a 4 point decrease in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), no increase in The British Isles Lupus Assessment Group (BILAG) Index score and no more of an increase in Physician's Global Assessment (PGA) than 10% of the scale. As assessed here, there must also be no off protocol increase in medications. All scales signify worsening disease when scores increase. Ranges on BILAG could be 0-108 but are rarely greater than 36. SLEDAI could range 0-105 but is rarely greater than 20. PGA 0-100 but rarely greater than 76.
| Participants | Extended Release Dipyridamole/Aspirin | Aspirin |
|---|---|---|
| Systemic Lupus Erythematosus Responder Index (SRI) 4 | 3 | 2 |
This is a landmark analysis of percentage of patients who, compared to baseline, have a 4 point drop in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). A 4 point decrease signifies a clinically significant decrease in disease activity as reported in many studies and as commonly used as a clinical endpoint in trials. SLEDAI could range 0-105 but is rarely greater than 20.
| Participants | Extended Release Dipyridamole/Aspirin | Aspirin |
|---|---|---|
| SRI Component Analyses: 4 Point Drop in SLEDAI | 4 | 2 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Extended Release Dipyridamole/Aspirin | 0/13 (0%) | 0/13 (0%) | 13/13 (100%) |
| Aspirin | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Event | Extended Release Dipyridamole/Aspirin | Aspirin |
|---|---|---|
| HysterectomyReproductive system and breast disorders | 0/13 | 1/5 |
| Event | Extended Release Dipyridamole/Aspirin | Aspirin |
|---|---|---|
| GastroenteritisGastrointestinal disorders | 8/13 | 3/5 |
| Upper Respiratory InfectionInfections and infestations | 1/13 | 3/5 |
| Urinary Tract InfectionInfections and infestations | 3/13 | 2/5 |
| Spider BiteInjury, poisoning and procedural complications | 0/13 | 2/5 |
| HeadacheNervous system disorders | 4/13 | 1/5 |
| PneumoniaInfections and infestations | 1/13 | 1/5 |
| DizzinessNervous system disorders | 0/13 | 1/5 |
| urticariaImmune system disorders | 2/13 | 0/5 |
| Bladder Outlet ObstructionRenal and urinary disorders | 1/13 | 0/5 |
| Chest PainMusculoskeletal and connective tissue disorders | 1/13 | 0/5 |
| Age, Continuous(years) | Extended Release Dipyridamole/Aspirin | Aspirin | Total |
|---|---|---|---|
| Mean | 44.5 ± 12.0 | 43.8 ± 12.9 | 44.3 ± 11.9 |
| Sex: Female, Male(Participants) | Extended Release Dipyridamole/Aspirin | Aspirin | Total |
|---|---|---|---|
| Female | 12 | 5 | 17 |
| Male | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Extended Release Dipyridamole/Aspirin | Aspirin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 9 | 4 | 13 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Extended Release Dipyridamole/Aspirin | Aspirin | Total |
|---|---|---|---|
| United States | 13 | 5 | 18 |
| Mean BILAG Score at Entry(units on a scale) | Extended Release Dipyridamole/Aspirin | Aspirin | Total |
|---|---|---|---|
| Mean | 11.2 ± 4.4 | 10 ± 4.9 | 10.9 ± 4.4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Those who wish access to this data may contact Joan Merrill at joan-merrill@omrf.org for further information
Supporting information: Study protocol
Time frame: The data will be available on or before June 1 2021
Access criteria: For de-identified data only: Please submit a two page request describing the research you wish to do and the investigators credentials and current employment. This will be reviewed by our cohort advisory board and IRB prior to release.
Ran from Feb 2013 to primary completion in May 2017, 51 months.
Results were first posted in Nov 2020, 3 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic →
Oklahoma Medical Research Foundation