Here is the design of a clinical trial:

Official Title: Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST). A Randomised-controlled Trial of Thrombolytic Treatment With Tenecteplase for Acute Ischaemic Stroke Upon Awakening

Included conditions:
- Ischemic Stroke
- Stroke, Acute

Study Armgroups:
- {'label': 'Tenecteplase', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tenecteplase + Best standard treatment', 'interventionNames': ['Drug: Tenecteplase']}
- {'label': 'Control', 'type': 'OTHER', 'description': 'No tenecteplase + Best standard treatment', 'interventionNames': ['Other: Control']}

Interventions:
- {'type': 'DRUG', 'name': 'Tenecteplase', 'description': 'Single dose intravenous injection of recombinant fibrin-specific tissue plasminogen activator (tenecteplase) 0.25 mg (200 IU) per kg body weight up to a maximum of 25 mg (5000 IU), given as a bolus over approx. 10 seconds.', 'armGroupLabels': ['Tenecteplase'], 'otherNames': ['Metalyse']}
- {'type': 'OTHER', 'name': 'Control', 'description': 'Best standard treatment', 'armGroupLabels': ['Control']}

Primary Outcomes:
- {'measure': 'Functional outcome at 3 months.', 'description': 'Functional outcome will be assessed by the modified Rankin Scale (mRS), values 0-6', 'timeFrame': '3 months'}

Please estimate the sample size based on the assumption: 
Power of 80%, two-sided significance level of 5%
Sample size estimates
        We assume a treatment effect of 10% absolute difference in a binary endpoint setting (mRS 0â1 vs. mRS 2â6) and a distribution between modified Rankin Scale categories similar to that of the WAKE-UP trial
3
 with 42% with favourable outcome in the non-thrombolysed group versus 52% in the thrombolysed group, corresponding to an odds ratio of 1.50. Assuming an effect size specified as an odds ratio of 1.5 from an ordinal logistic regression model and similar distribution of mRS scores in the control group in six levels as in the WAKE-UP trial (categories 5 and 6 merged) of 15%, 27%, 23%, 17%, 13%, and 5%
3
, the estimated sample size of 600 patients yields a power of 80%, with a two-sided significance level of 5%.