ClinicalTrials.gg
RecruitingNCT06653348DEDAPT-TICAUpdated Apr 27, 2025

Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke

A Phase 2/3 interventional study of Ticagrelor 60 + Aspirin and Ticagrelor 90 + aspirin in Ischemic Stroke and Transient Ischemic Attack, sponsored by Mazandaran University of Medical Sciences. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by Mazandaran University of Medical Sciences · Phase 2/3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Apr 2024, registered Oct 2024).
  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

This is a randomized, controlled, outcome assessor blind, parallel group design pilot study on 100 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari,Iran.The aim of study is to compare the efficacy of 90 mg ticagrelor BID plus aspirin for 1 month and 60 mg ticagrelor BID plus aspirin for 6 months in reduce of non-disabling non-cardioembolic ischemic stroke or high risk TIA recurrence during first 12 months.

Read the detailed description

This is a randomized, controlled, parallel, outcome assessor blind, feasibility study. The aim of study is assess the efficacy of ticagrelor de-escalation in reduce of non-disabling non-cardioembolic ischemic stroke or high risk TIA recurrence during first 12 months after primary event. 100 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari, Iran will be randomized to intervention or control group by using 4 block randomization method. Inclusion criteria is : age>40, signing inform consent, recent ischemic stroke within 24 h, diagnosed by brain CT or MRI mild stroke with NIHSS =\<8 and no evidence of large infarct in brain imaging.,high risk TIA with ABCD >4, no cardioembolic source such as low E/F, MS, AF ,... no specific etiology such as dissection, vasculitis, ... no carotid stenosis > 50 % in side of involvement. Exclusion criteria is :history of hypersensitivity to consumptive drug any indication for anticoagulant therapy acute phase treatment with intravenous thrombolysis or thrombectomy any contraindication for consumptive drug history of intracranial hemorrhage history of GI bleeding during past 6 m candidate for endarterectomy history of coagulopathy active hemorrhagic diathesis during randomization. Patients in control group will be treat with standard ischemic stroke regiment including ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg and ticagrelor 90 mg BID for 1 month. Then single antiplatelet therapy with ASA will be continue. Intervention group will be treat with ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg daily and ticagrelor 90 mg BID for 1 month. And, Ticagrelor 60 mg BID plus ASA 80 mg daily until the end of month 6. Then single antiplatelet therapy with ASA will be continue. Four fallow up visit plan by a neurologist or neurology resident on month 1, 3, 6 and 12.Clinical data including NIHSS score, MRS score and other data will record on case report form. Stroke recurrence or cardiovsacular event is efficacy end point. Major bleeding according to STIH criteria is study safety end point. Primary outcome is ischemic stroke recurrence during first 12 months after first event documented by new lesion on brain CT or MRI. Secondary outcome is major hemorrhagic events, stroke recurrence during first 6 months and any cardiovascular event during first 12 month.

02

Conditions studied

  • Ischemic Stroke
  • Transient Ischemic Attack

Keywords

  • ischemic stroke
  • non-cardioembolic
  • non-disabling
  • TIA
  • Ticagrelor
  • de-escalation
  • dual antiplatelet therapy
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Mazandaran University of Medical Sciences is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • signing inform consent,
  • recent ischemic stroke within 24 h,
  • diagnosed by brain CT or MRI mild stroke with NIHSS =\<8 and no evidence of large infarct in brain imaging
  • high risk with ABCD >4,
  • no cardioembolic source such as low E/F, MS, AF ,...
  • no specific etiology such as dissection, vasculitis, ...
  • no carotid stenosis > 50 % in side of involvement

Exclusion criteria

Exclusion Criteria:

  • history of to consumptive drug
  • any indication for anticoagulant therapy
  • acute phase treatment with intravenous thrombolysis or thrombectomy
  • any for consumptive drug
  • history of intracranial hemorrhage
  • history of GI bleeding during past 6 m
  • candidate for endarterectomy
  • history of coagulopathy
  • active hemorrhagic diathesis during randomization
Terms in these criteria, in plain language(3)

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.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    intervention

    Intervention group will be treat with ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg daily and ticagrelor 90 mg BID for 30 days. Then ticagrelor 60 mg BID and ASA 80 mg daily until the end of month 6.

    Drug: Ticagrelor 60 + Aspirin

  • Active comparator
    comparator

    Comparator group will be treat with ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg daily and ticagrelor 90 mg BID for 30 days. Then ASA 80 mg daily until the end of month 6.

    Drug: Ticagrelor 90 + aspirin

Interventions

  • DrugTicagrelor 60 + Aspirin

    Ticagrelor 90 mg BID plus ASA 80 mg daily for 1 month and then ticagrelor 60 mg BID plus ASA 80 mg daily until the end of month 6.

  • DrugTicagrelor 90 + aspirin

    ticagrelor 90 mg BID plus ASA 80 mg daily for 1 month.

06

What researchers measure

Primary outcomes

  1. ischemic stroke recurrence

    recording new event based on new lesion on brain CT scan or MRI

    Time frame: 12 months

Secondary outcomes

  1. Major hemorrhagic event

    Major bleeds were defined according to the International Society of Thrombosis and Hemostasis (ISTH)

    Time frame: during first 180 days

07

Study locations

1 of 1 sites recruiting
  • Mazandaran province, Sari,Iran
    Sari, Mazandaran 4817844718, Iran, Islamic Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06653348
Lead sponsor
Mazandaran University of Medical Sciences
Responsible party
Athena Sharifi Razavi (Dr. Athena Sharifi Razavi, Mazandaran University of Medical Sciences) — Principal investigator
First posted
Oct 22, 2024
Start date
Apr 1, 2024
Primary completion
Jul 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Apr 27, 2025

Study contacts

Athena Sharifi Razavi, MD
Contact
athena.sharifi@yahoo.com
+989113510136
Nasim Tabrizi, MD
Contact
nasimtabrizi@gmail.com
00989111263538

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion