Table 1

Trial assessment flow chart

−4.5 hours0 hour24±2 hours24–36 hoursDay 7±1 or dischargeDay 90±7
Informed consent*X
Demographic dataX
Symptoms of the diseaseX
Medical history†X
Prior medicationX
Concomitant medication‡XXXXXX
Vital signs§XXXX
Barthel IndexX
Pregnancy tests**X
Laboratory assessments††
Clinical chemistryXXX
Coagulation profileXXX
Thrombolysis information‡X
Adverse events/Serious adverse events assessmentXXXXX
  • *Patients who had symptoms on awakening or unknown onset were excluded in the study.

  • †Prior medication is recorded only for those drugs that need to be restricted in the eligibility criteria.

  • ‡Thrombolysis information includes the time of thrombolytic therapy in both groups (including the intravenous bolus time, the starting and ending time of maintenance infusion, the dose of the bolus and the maintenance infusion, the adverse events); pay attention to collecting information of bridging treatment.

  • §The baseline blood pressure test is collected at the time of vital signs collection; The ‘0 hour’ visit is regarded as within 5 min before thrombolysis; vital signs include blood pressure, pulse, temperature and breath.

  • ¶The mRS scores screened into the group indicate preonset score.

  • **Pregnancy test is limited to female subjects of childbearing age.

  • ††Laboratory assessments: (1) baseline laboratory assessments include haematology, clinical chemistry and coagulation profile; no need to repeat the assessments performed after the attack and before thrombolysis. Fasting blood is required for the baseline lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides). Fast glucose is allowed to decide eligibility criteria with serum glucose collected synchronously. The clinical chemistry results are available after the administration of study drugs. The investigators will deal with the abnormal results according to guidelines and the clinical pathway if necessary. (2) The laboratory assessments of 72 hours after thrombolysis, including haematology, clinical chemistry, coagulation profile and urinalysis, can be acceptable for the 24 hours visit. (3) Haematology, clinical chemistry, coagulation profile and urinalysis should be done at 7±1 days or before discharge (whichever occurs first).

  • ‡‡No need to repeat ECG after the attack and before thrombolysis.

  • §§The baseline imaging, whatever ‘CT or MRI’, is used to exclude intracranial haemorrhage. Imaging data from another hospital is accepted according to investigators. The follow-up imaging (CT or MRI) should be completed within 24–36 hours to detect intracranial haemorrhage.

  • mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.