NCT04484259 (OPTIMUS-7) is a Phase 4 clinical trial of Ticagrelor monotherapy in Diabetes Mellitus, Type 2, sponsored by University of Florida.

Who is sponsoring NCT04484259?

NCT04484259 is sponsored by University of Florida.

What drugs are being tested in NCT04484259?

Interventions in NCT04484259: Ticagrelor monotherapy, Ticagrelor plus aspirin, Clopidogrel with aspirin.

What condition does NCT04484259 study?

NCT04484259 studies Diabetes Mellitus, Type 2, Coronary Artery Disease.

Is NCT04484259 still recruiting?

NCT04484259 is currently completed. Last updated 30 March 2025.

Are results published for NCT04484259?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-30 · How we verify

NCT04484259: OPTIMUS-7

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus

Completed Phase 4 Results posted Last updated 30 March 2025

What this trial tests

Phase 4 trial testing Ticagrelor monotherapy in Diabetes Mellitus, Type 2 in 105 participants. Completed in 15 June 2024.

Timeline

31 March 2021

Primary endpoint
29 January 2024

15 June 2024

Quick facts

Lead sponsor	University of Florida
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	31 March 2021
Primary completion	29 January 2024
Estimated completion	15 June 2024
Sites	1 location across United States

Drugs / interventions tested

Ticagrelor monotherapy — full drug profile →
Ticagrelor plus aspirin — full drug profile →
Clopidogrel with aspirin — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

University of Florida

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2 or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recent studies have shown that withdrawing aspirin and maintaining P2Y12 inhibitor monotherapy for up to 12 months post-PCI, after a brief period of DAPT, reduces bleeding without increasing ischemic harm. Such effects have shown to of particular benefit in patients with diabetes mellitus (DM). However, if an aspirin-free approach can be considered after this time frame is a matter of debate. The aim of this study is to assess the PD effects of ticagrelor 60 mg with and without aspirin therapy in CAD patients and to compare this with a standard DAPT regimen of aspirin plus clopidogrel.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

The developmental journey of therapies targeting purine receptors: from basic science to clinical trials.
Han S, Suzuki-Kerr H, Vlajkovic SM, Thorne PR. · · 2022 · cited 9× · PMID 36173587 · DOI 10.1007/s11302-022-09896-w
Contemporary Percutaneous Coronary Intervention in Diabetic Patients.
Tartaglia F, Filiberti G, Bernardini V, Gitto M, et al · · 2025 · PMID 41524061 · DOI 10.31083/rcm44861
Current status of percutaneous coronary interventions in diabetics with multivessel disease - is it time to challenge FREEDOM?
Kaul U, Sudhir K, Bangalore S. · · 2024 · PMID 39070972 · DOI 10.4244/aij-d-24-00016

Verify or expand the search:

Other trials of Ticagrelor monotherapy

Trials testing the same drug.

NCT06015477 — Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Unruptured Intracrania · NA · unknown

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting

Other University of Florida trials

Trials by the same sponsor.

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NCT06127550 — taVNS for Letter Learning in Dyslexia · NA · suspended
NCT07507214 — Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athl · Phase 2, PHASE3 · not yet recruiting
NCT07492316 — RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB) · Phase 1 · not yet recruiting
NCT06670794 — Using Ecological Momentary Data to Inform a Web Intervention for Romantic Partners Concerned About Their Loved Ones' Dri · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04484259 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Florida
Last refreshed: 30 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04484259.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing