Rationale and design of Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events III (TRACE III): a randomised, phase III, open-label, controlled trial

Trial assessment flow chart. DWI, diffusion-weighted imaging; mRS, modified Rankin Scale.*Key time points include onset time, hospitalization time and thrombolysis time; †The baseline blood pressure test is collected at the time of vital signs collection; The "Oh" visit is regarded as within 5 minutes before thrombolysis; Vital signs include blood pressure, pulse, temperature and respiratory rate; ‡The mRS scores screened into the group include premorbid score and post-onset score before thrombolysis; §Pregnancy test is limited to female subjects of childbearing age; ¶Laboratory assessments: Baseline laboratory assessments include hematology, 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. (1) The laboratory assessments of 72h after thrombolysis, including hematology, clinical chemistry, coagulation profile and urinalysis, can be acceptable for the 24h visit. (2) Hematology, 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 hemorrhage. CT angiography (CTA)+ CT perfusion (CTP) or MRI perfusion weighted imaging (MRI_PWI) +MR angiography (MRA) was used to identify large vessel occlusion and target mismatch. The follow-up imaging CT +CTA + CTP (or MRI_DWI +MRA + PWI) need to be completed at 24 + 6h of randomization to assess vessel recanalization and tissue reperfusion. CT or MRI need to be completed within 36 ± 6h to detect intracranial hemorrhage, if patient's sign remain stable, then 24 ± 6h CT or MRI can be used as the evaluation imaging for intracranial hemorrhage and no need to repeat the CT or MRI at 36 ± 6h. §§Thrombolysis information includes the time of thrombolytic therapy in treatment group (including the intravenous bolus time, the dose of the bolus and the adverse events).