Ignite Creation Date:
2024-05-06 @ 12:49 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01661322
Status:
TERMINATED
Last Update Posted:
2018-06-11
First Post:
2012-07-23
Brief Title:
Triple Antiplatelets for Reducing Dependency After Ischaemic Stroke
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Safety and Efficacy of Intensive Versus Guideline Antiplatelet Therapy in High Risk Patients With Recent Ischaemic Stroke or Transient Ischaemic Attack a Randomised Controlled Trial
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial reached a definitive answer ahead of full recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARDIS
Brief Summary:
The risk of recurrence is greatest immediately after stroke or Transient Ischaemic Attack TIA Existing prevention strategies antithrombotic lipidblood pressure lowering endarterectomy reduce not abolish further events Dual antiplatelet therapy - aspirin clopidogrel AC for IHD aspirin dipyridamole AD for stroke is superior to aspirin monotherapy The investigators hypothesise that triple antiplatelet therapy ACD will be superior to AD in patients at high-risk of recurrence providing bleeding does not become excessive
Design TARDIS is a multicentre parallel-group prospective randomised open-label blinded-endpoint controlled trial In the start-up phase the investigators will assess over 3 years the safety tolerability and feasibility of intensive therapy ACD versus guideline therapy AD given for 1 month in 750 patients with acute strokeTIA The main phase will then assess the safety and efficacy of ACD in up to 3500 patients The primary outcome is ordinal stroke fatalsevere non-fatalmildTIAnone at 90 days Secondary outcomes include death MI vascular events function bleeding serious adverse events sub-studies will assess cerebral emboli and platelet function
Design TARDIS is a multicentre parallel-group prospective randomised open-label blinded-endpoint controlled trial In the start-up phase the investigators will assess over 3 years the safety tolerability and feasibility of intensive therapy ACD versus guideline therapy AD given for 1 month in 750 patients with acute strokeTIA The main phase will then assess the safety and efficacy of ACD in up to 3500 patients The primary outcome is ordinal stroke fatalsevere non-fatalmildTIAnone at 90 days Secondary outcomes include death MI vascular events function bleeding serious adverse events sub-studies will assess cerebral emboli and platelet function
Detailed Description:
21 Purpose To perform a randomised trial assessing the efficacy safety and tolerability of intensive antiplatelet therapy AspDipClop versus guideline antiplatelet therapy AspDip or Clop in patients with recent ischaemic stroke or TIA and who are at high risk of recurrence
22 Primary Objective To assess ordinal stroke severity at 90 days after short-term administration 1 month of intensive antiplatelet therapy versus guideline therapy in patients with very recent ischaemic stroke or TIA
23 Secondary Objectives
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 strokeTIA 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
22 Primary Objective To assess ordinal stroke severity at 90 days after short-term administration 1 month of intensive antiplatelet therapy versus guideline therapy in patients with very recent ischaemic stroke or TIA
23 Secondary Objectives
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 strokeTIA 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-006749-42 | EUDRACT_NUMBER | None | None |