Is intensive blood thinning with three antiplatelet drugs better than the current guideline treatment in reducing recurrence after acute stroke?

Safety and efficacy of clopidogrel when added to aspirin and dipyridamole in high risk patients with recent ischaemic stroke or TIA: a randomised controlled trial - TARDIS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-006749-42-GB

Enrollment

4100

Registered

2008-10-20

Start date

2009-01-09

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic stroke and TIA (transient ischaemic attack) MedDRA version: 14.1 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: PT Classification code 10044390 Term: Transient ischaemic attack System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Clopidogrel Pharmaceutical Form: Tablet INN or Proposed INN: CLOPIDOGREL CAS Number: 113665-84-2 Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults at high risk of recurrent ischaemic stroke: 1. Acute high risk TIAs =65 years) yes F.1.3.1 Number of subjects for this age range 2665

Exclusion criteria

Exclusion criteria: 1. Age2). 15. Severe high BP (BP>185/110 mmHg). 16. Haemoglobin less than 10g/dL 17. Platelet count more than 600 x 109 /L or less than 100 x 109 /L 18. White cell count more than 30 x 109 /L or less than 3.5 x 109 /L 19. Major bleeding within 1 year (e.g. peptic ulcer, intracerebral haemorrhage). 20. Planned surgery during 3 month follow-up (e.g. carotid endarterectomy) 21. Concomitant STEMI or NSTEMI. 22. Stroke secondary to a procedure (e.g. carotid or coronary intervention) 23. Coma (GCS<8) 24. Non-stroke life expectancy<6 months 25. Dementia 26. Participation in another drug or devices trial concurrently or within 30 days. (participants may take part in observational studies or non-drug or devices trials) 27. Geographical or other factors that may interfere with follow-up e.g. no fixed address or telephone contact number, not registered with a GP, or overseas visitor. 28. Females of childbearing potential, pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety of short-term administration (1 month) of intensive antiplatelet therapy (aspirin, dipyridamole and clopidogrel) versus current guideline therapy (dual aspirin and dipyridamole, or clopidogrel monotherapy) in patients with very recent ischaemic stroke or TIA.;Primary end point(s): The trial will assess ordinal stroke severity: 5-level ordinal stroke and TIA scale with stroke ordered by its severity using the modified Rankin Scale (mRS): fatal stroke / severe non-fatal stroke (mRS 2-5) / mild stroke (mRS 0,1) / TIA / no stroke-TIA, measured at 90 days.;Timepoint(s) of evaluation of this end point: 8 years 3 months; Secondary Objective: 1. To assess the safety of short-term administration (1 month) of intensive antiplatelet therapy versus guideline therapy in patients with very recent ischaemic stroke or TIA. 2. To further assess, in high risk patients with stroke/TIA, whether: ii. it is feasible to administer intensive therapy acutely and is tolerable to take for 1 month, iii. intensive therapy is superior in respect of surrogate markers such as platelet function. iv. intensive therapy improves functional outcome	—

Measure

Time frame

Main Objective: To assess the safety of short-term administration (1 month) of intensive antiplatelet therapy (aspirin, dipyridamole and clopidogrel) versus current guideline therapy (dual aspirin and dipyridamole, or clopidogrel monotherapy) in patients with very recent ischaemic stroke or TIA.;Primary end point(s): The trial will assess ordinal stroke severity: 5-level ordinal stroke and TIA scale with stroke ordered by its severity using the modified Rankin Scale (mRS): fatal stroke / severe non-fatal stroke (mRS 2-5) / mild stroke (mRS 0,1) / TIA / no stroke-TIA, measured at 90 days.;Timepoint(s) of evaluation of this end point: 8 years 3 months; Secondary Objective: 1. To assess the safety of short-term administration (1 month) of intensive antiplatelet therapy versus guideline therapy in patients with very recent ischaemic stroke or TIA. 2. To further assess, in high risk patients with stroke/TIA, whether: ii. it is feasible to administer intensive therapy acutely and is tolerable to take for 1 month, iii. intensive therapy is superior in respect of surrogate markers such as platelet function. iv. intensive therapy improves functional outcome

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Safety outcome - bleeding at 35 days (end of treatment). 2. Functioning, cognition and quality of life. ; Timepoint(s) of evaluation of this end point: 1. Safety outcome - bleeding. Interim analysis at 4 years and end of trial at 8 years and 3 months. 2. Functional cognition, QUOL outcomes - 8 years 3 months.	—

Countries

Denmark, United Kingdom

Contacts

Public ContactTARDIS Trial Office

University of Nottingham

tardis@nottingham.ac.uk+4401158230210

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 10, 2026