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Clinical trial

Triple Antiplatelets for Reducing Dependency After Ischaemic Stroke (TARDIS)

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Last updated:1st May 2009
Primary Outcome Measures:
  • The primary outcome is ordinal stroke severity at 90 days [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]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.; this approach allows for smaller sample sizes compared to binary outcomes such as stroke/no stroke

Secondary Outcome Measures:
  • Safety [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

          Days 7 and 35 Full blood count by local investigator

Days 7, 35 and 90:

  • Ordinal bleeding (fatal/major/moderate/minor/none42) as adjudicated by an independent blinded panel; death; binary major bleeding (fatal, symptomatic, causing fall in haemoglobin of ≥2g/l, or leading to transfusion of ≥2 units of blood/red cells);45 binary minor bleeding (e.g. bruising) binary bleeding; all bleeding, symptomatic intracerebral haemorrhage, major extracranial bleeding, binary serious adverse events, ordinal adverse events (fatal/serious/other/none42); thrombotic thrombocytopenic purpura; granulocytopenia.

 

  • Serious adverse events [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Platelet function. [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]   

Days 7 and 35 Full blood count by local investigator Days 7, 35 and 90: Ordinal bleeding (fatal/major/moderate/minor/none42) as adjudicated by an independent blinded panel; death; binary major bleeding (fatal, symptomatic, causing fall in haemoglobin of ≥2g/l, or leading to transfusion of ≥2 units of blood/red cells);45 binary minor bleeding (e.g. bruising) binary bleeding; all bleeding, symptomatic intracerebral haemorrhage, major extracranial bleeding, binary serious adverse events, ordinal adverse events (fatal/serious/other/none42); thrombotic thrombocytopenic purpura; granulocytopenia.

Category Value
Study start date 2009-05-01

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