TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue
TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue
This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot.
The purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke.
Participants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment.
Participants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.
Inclusion criteria:
Exclusion criteria:
clintriage.rdg@boehringer-ingelheim.com1-800-243-0127
Buenos Aires, C1180AAX, Argentina
argentina@bitrialsupport.com08002667801
Ciudad Autonoma Buenos Aires, 1199, Argentina
argentina@bitrialsupport.com08002667801
Ciudad Autonoma Buenos Aires, 1431, Argentina
argentina@bitrialsupport.com08002667801
Ciudad Autonoma Buenos Aires, C1221ADC, Argentina
argentina@bitrialsupport.com08002667801
Ciudad Autonoma Buenos Aires, C1426EOB, Argentina
argentina@bitrialsupport.com08002667801
Ciudad Autonoma Buenos Aires, C1428AQK, Argentina
argentina@bitrialsupport.com08002667801
Ciudad Autonoma Buenos Aires, C1437JCP, Argentina
argentina@bitrialsupport.com08002667801
Pleven, 5803, Bulgaria
Silven, 8800, Bulgaria
balgariya@bitrialsupport.com024903378
Changsha, 410005, China
Haerbin, 150086, China
china@bitrialsupport.com4001200553
Luoyang, 471000, China
Athens, Neo Faliro, 185 47, Greece
hellas@bitrialsupport.com008000000092
Chandigarh, 160012, India
Rohtak, 124001, India
Thiruvananthapuram, 695011, India
Constanța, 900591, Romania
Klong Luang, 12120, Thailand
thai@bitrialsupport.com1800019059
Muang, 34000, Thailand
thai@bitrialsupport.com1800019059
argentina@bitrialsupport.com08002667801
argentina@bitrialsupport.com08002667801
argentina@bitrialsupport.com08002667801
argentina@bitrialsupport.com08002667801
argentina@bitrialsupport.com08002667801
argentina@bitrialsupport.com08002667801
argentina@bitrialsupport.com08002667801
argentina@bitrialsupport.com08002667801
argentina@bitrialsupport.com08002667801
australia@bitrialsupport.com1800271035
australia@bitrialsupport.com1800271035
australia@bitrialsupport.com1800271035
australia@bitrialsupport.com1800271035
australia@bitrialsupport.com1800271035
australia@bitrialsupport.com1800271035
australia@bitrialsupport.com1800271035
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
balgariya@bitrialsupport.com024903378
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
china@bitrialsupport.com4001200553
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
hellas@bitrialsupport.com008000000092
magyarorszag@bitrialsupport.com680017725
magyarorszag@bitrialsupport.com680017725
magyarorszag@bitrialsupport.com680017725
magyarorszag@bitrialsupport.com680017725
magyarorszag@bitrialsupport.com680017725
magyarorszag@bitrialsupport.com680017725
magyarorszag@bitrialsupport.com680017725
magyarorszag@bitrialsupport.com680017725
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
india@bitrialsupport.com0008000501442
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
support@bitrialsupport.com00441144040048
kazakhstan@bitrialsupport.com88000808264
kazakhstan@bitrialsupport.com88000808264
malaysia@bitrialsupport.com1800814353
malaysia@bitrialsupport.com1800814353
malaysia@bitrialsupport.com1800814353
malaysia@bitrialsupport.com1800814353
malaysia@bitrialsupport.com1800814353
malaysia@bitrialsupport.com1800814353
norge@bitrialsupport.com80058261
norge@bitrialsupport.com80058261
norge@bitrialsupport.com80058261
romania@bitrialsupport.com0800895209
romania@bitrialsupport.com0800895209
romania@bitrialsupport.com0800895209
romania@bitrialsupport.com0800895209
romania@bitrialsupport.com0800895209
romania@bitrialsupport.com0800895209
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
espana@bitrialsupport.com900876092
taiwan@bitrialsupport.com0809092098
taiwan@bitrialsupport.com0809092098
taiwan@bitrialsupport.com0809092098
taiwan@bitrialsupport.com0809092098
taiwan@bitrialsupport.com0809092098
taiwan@bitrialsupport.com0809092098
taiwan@bitrialsupport.com0809092098
taiwan@bitrialsupport.com0809092098
taiwan@bitrialsupport.com0809092098
thai@bitrialsupport.com1800019059
thai@bitrialsupport.com1800019059
thai@bitrialsupport.com1800019059
thai@bitrialsupport.com1800019059
thai@bitrialsupport.com1800019059
thai@bitrialsupport.com1800019059
thai@bitrialsupport.com1800019059
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473
vietnam@bitrialsupport.com01800545473