Statistical analysis plan for the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS)...

Area of Science:

• Neurology
• Cardiology
• Clinical Trials

Background:

• Antiplatelet agents are crucial for reducing stroke recurrence.
• The highest risk of stroke recurrence occurs immediately post-event.
• Antiplatelet therapy carries a risk of bleeding.

Purpose of the Study:

• To evaluate the safety and efficacy of short-term intensive antiplatelet therapy.
• To compare intensive therapy against standard guideline-based therapy for reducing early stroke recurrence.
• The 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial investigates this approach.

Main Methods:

• International, multi-center, prospective, randomized, open-label, blinded-endpoint trial.
• Patients with acute ischemic stroke or transient ischemic attack randomized within 48 hours.
• Comparison of one-month intensive/triple antiplatelet therapy versus guideline antiplatelets.

Main Results:

• The primary outcome is the shift in stroke recurrent events and their severity at three months.
• Modified Rankin Scale is used to assess outcomes.
• Intention-to-treat analyses will be performed.

Conclusions:

• The TARDIS trial will provide the first large-scale randomized evidence on intensive antiplatelet therapy post-stroke.
• The study aims to inform clinical practice regarding early stroke recurrence prevention.
• The statistical analysis plan is detailed prior to data unblinding.