TY - JOUR
T1 - Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial: Rationale, design and progress
AU - Anderson, Craig S.
AU - Rodgers, Anthony
AU - Asita de Silva, H.
AU - Martins, Sheila Ouriques
AU - Klijn, Catharina JM
AU - Senanayake, Bimsara
AU - Freed, Ruth
AU - Billot, Laurent
AU - Arima, Hisatomi
AU - Thang, Nguyen Huy
AU - Zaidi, Wan Asyraf Wan
AU - Kherkheulidze, Tinatin
AU - Wahab, Kolawole
AU - Fisher, Urs
AU - Lee, Tsong-Hai
AU - Chen, Christopher
AU - Pontes-Neto, Octavio M.
AU - Robinson, Thompson
AU - Wang, Jiguang
AU - Naismith, Sharon
AU - Song, Lili
AU - Schreuder, Floris H
AU - Lindley, Richard I.
AU - Woodward, Mark
AU - MacMahon, Stephen
AU - Salman, Rustam Al-Shahi
AU - Chow, Clara K
AU - Chalmers, John
AU - TRIDENT Research Group
AU - Martins, Sheila O
AU - Fischer, Urs
AU - Sandercock, Peter
AU - Berge, Eivind
AU - Hankey, Graeme J.
AU - Algra, Ale
AU - Wermer, Marieke
AU - Hillis, Graham
AU - Wong, K.S. Lawrence
AU - Li, Qiang
AU - Wang, Xia
AU - Delcourt, Candice
AU - do Espirito Santo, Karla Rodrigues
AU - Carcel, Cheryl
AU - Kaur, Baldeep
AU - Espinosa, Natalie
AU - Lim, Joyce
AU - Cheung, Tina
AU - Gao, Annie
AU - Higgins, Kathryn
AU - Balicki, Grace
AU - Hatchwell, Luke
AU - Armenis, Manuela
AU - Malone, Magdalen
AU - de Souza, Ana Claudia
AU - Miyamoto, Kendi Nishino
AU - Kakabadze, Nodar
AU - Chen, Shanny
AU - Bee, Seu Siow
AU - Foo, Rachel
AU - Tan, Lee Mei
AU - Chien, Maximus
AU - Chen, Curtis
AU - Hoogland, Rinske
AU - Telufusi, Adebukunola
AU - Ogunkoya, Faramola
AU - Ibeh, Cornelius
AU - Onyeanu, Joseph
AU - Oladimeji, Olalekan
AU - Salami, Sodiq
AU - Durojaiye, Tobi
AU - Teo Kee Ling, Connie
AU - Shan, Hui
AU - Weerawardena, Shalomi
AU - Budurdeen, Sadiya
AU - Ellawala, Poornima
AU - Wijesinghe, Namal
AU - Dahanayaka, Anuradha
AU - Jeevarajah, Thanushanthan
AU - Gnanapragasam, Seraina
AU - Innes, Karen
AU - Whittaker, Clare
AU - Stewart, Kelly
AU - Dinsmore, Lynn
AU - Moullaali, Tom
AU - Uyen, Hong Ha
AU - Tram, Ngo Thi Bich
AU - Nguyen, Thu
AU - Yen, Mai
AU - Linh, Le
AU - Ang, T.
AU - Mitchell, N.
AU - Cordato, D.
AU - Miller, M
AU - Kinchington, M
AU - Steel, J.
AU - Grimley, R.
AU - Witness, E.
AU - Simmons, K
AU - Ghia, D.
AU - Edmonds, G.
AU - Whittaker, KA.
AU - Ewing, M.
AU - Yassi, N.
AU - Jackson, D.
AU - Brown, H.
AU - Bendal, C.
AU - Mora Cuervo, D.L.
AU - Weiss, G.
AU - Batista, C.
AU - Reckziegel, E.
AU - Secchi, T.
AU - Nasi, F.
AU - Santos, F.
AU - Pille, A.
AU - Tavares, G.L.
AU - Camilo, M.
AU - Arruda, R.
AU - Lyra, V.
AU - Silva, G.
AU - Barros, F.C.D.
AU - Rodrigues, D.L.
AU - Fagundes, D.
AU - Atika, J.
AU - Teodoro, R.
AU - Alves, K.
AU - Bazan, R.
AU - Moro, C.H.C.
AU - Santos, R.
AU - Battaglini, M.
AU - Souza, A.
AU - Alves, F.
AU - Dracoulakis, M.
AU - Oliveira Lima, F.
AU - Hommem, H.
AU - Rebello, L.
AU - Silva, T.
AU - Zétola, V.
AU - Lange, M.
AU - Scavasine, V.C.
AU - Imerlishvili, N.
AU - Lursmanashvili, L.
AU - Zarandia, M.
AU - Kipshidze, I.
AU - Beridze, M.
AU - Losaberidze, T.
AU - Tsiskaridze, A.
AU - Lobjanidze, N.
AU - Janelidze, M.
AU - Bochorishvili, N.
AU - Fadzil, F.
AU - Looi, I.
AU - Chin, C. J.
AU - Suppiah, PD.
AU - Ng, L.Y.
AU - Mohd Noor, J.
AU - Wan Chung, L.
AU - Steven, A.
AU - Cheng, WS.
AU - Gan, K.X.
AU - Chia, Y.K.
AU - Chew, S.H.
AU - Koh, KL
AU - Abdul-Halim, S.
AU - Imran Kamarudin, M.
AU - Che Rahim, MJ.
AU - Zakaria, Z.
AU - Malin Abdullah, J.
AU - Idris, Z.
AU - Wan Hassan, W.M.
AU - Mohd Sallehd, S.Z.
AU - Ismail, Z.
AU - Bello, A.H.
AU - Alabi, T.O.
AU - Sanyaolu, O.
AU - Bakare, A.
AU - Adeniyi, S.A.
AU - Obiako, R.
AU - Abubakar, S.A.
AU - Olurishe, C.
AU - Oguike, W.E.
AU - Osaigbovo, O.G.
AU - Amusa, G. A.
AU - Joseph, I.S.
AU - Olaniru, O.B.
AU - Ugoh, C.
AU - Okubadejo, N.
AU - Agabi, O.
AU - Ojo, O.
AU - Amuda-Oladeji, B.
AU - Udo, E.
AU - Opara, C.R.
AU - Akinyemi, R.
AU - Uvere, E.
AU - Siongco, PR.
AU - Nga, V.
AU - Udenika, A.K.
AU - Rajapakshe, I.
AU - Inaththappulige, S.R.
AU - Amarasena, P.
AU - Kumarasiri, A.
AU - Vithoosan, S.
AU - Mythily, S.
AU - Karunarathna, P.D.D.
AU - Rasmi, A.
AU - Jayasekara, O.D.
AU - Ranawaka, U.
AU - Mettananda, C.
AU - Munidasa, D.
AU - Somaratne, S.
AU - Nanayakkara, Y.P.
AU - Meegahapola, H.
AU - Joseph, D.
AU - Gunasekara, H.
AU - Wijeratne, G.
AU - Kariyawasam, B.
AU - Duwani, M.
AU - Liyakath, Z.
AU - Palliyaguruge, D.
AU - Bandara, P.J.S.
AU - Narayana, S.P.
AU - Sumanapala, J.S.
AU - Gallage, S.M.
AU - Abdul Rasheed, N.
AU - Hordagoda, H.
AU - Ralapanawa, U.
AU - Subasinghe, B.
AU - Rajendiran, T.
AU - Alwis, S.
AU - Liyanarachchi, V.
AU - Gunasekare, N.
AU - Peiris, J.
AU - Wickramasinghe, R.
AU - Fernando, C.
AU - Withanage, N.
AU - Bandara, M.
AU - Wijegunesinghe, D.
AU - Wijesena, S.
AU - De Mel, M.
AU - Abeysinghe, D.
AU - Wanni Arachchi, W.A.S.S.
AU - Liyanagamage, S.D.K.
AU - Keshavaraj, A.
AU - Kanagasabapathy, J.
AU - Gerald Jeevathasan, A.
AU - Mathyamuthan, J.P.
AU - Priyanth, A. John
AU - Dissanayake, A.
AU - Uluwattage, W.
AU - Chathurika, A.
AU - Rajinee, C.
AU - Jayawardana, S.
PY - 2022/12
Y1 - 2022/12
N2 - Background: Patients who suffer intracerebral hemorrhage (ICH) are at very high risk of recurrent ICH and other serious cardiovascular events. A single-pill combination (SPC) of blood pressure (BP) lowering drugs offers a potentially powerful but simple strategy to optimize secondary prevention. Objectives: The Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial (TRIDENT) aims to determine the effects of a novel SPC “Triple Pill,” three generic antihypertensive drugs with demonstrated efficacy and complementary mechanisms of action at half standard dose (telmisartan 20 mg, amlodipine 2.5 mg, and indapamide 1.25 mg), with placebo for the prevention of recurrent stroke, cardiovascular events, and cognitive impairment after ICH. Design: An international, double-blind, placebo-controlled, randomized trial in adults with ICH and mild-moderate hypertension (systolic BP: 130–160 mmHg), who are not taking any Triple Pill component drug at greater than half-dose. A total of 1500 randomized patients provide 90% power to detect a hazard ratio of 0.5, over an average follow-up of 3 years, according to a total primary event rate (any stroke) of 12% in the control arm and other assumptions. Secondary outcomes include recurrent ICH, cardiovascular events, and safety. Results: Recruitment started 28 September 2017. Up to 31 October 2021, 821 patients were randomized at 54 active sites in 10 countries. Triple Pill adherence after 30 months is 86%. The required sample size should be achieved by 2024. Conclusion: Low-dose Triple Pill BP lowering could improve long-term outcome from ICH.
AB - Background: Patients who suffer intracerebral hemorrhage (ICH) are at very high risk of recurrent ICH and other serious cardiovascular events. A single-pill combination (SPC) of blood pressure (BP) lowering drugs offers a potentially powerful but simple strategy to optimize secondary prevention. Objectives: The Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial (TRIDENT) aims to determine the effects of a novel SPC “Triple Pill,” three generic antihypertensive drugs with demonstrated efficacy and complementary mechanisms of action at half standard dose (telmisartan 20 mg, amlodipine 2.5 mg, and indapamide 1.25 mg), with placebo for the prevention of recurrent stroke, cardiovascular events, and cognitive impairment after ICH. Design: An international, double-blind, placebo-controlled, randomized trial in adults with ICH and mild-moderate hypertension (systolic BP: 130–160 mmHg), who are not taking any Triple Pill component drug at greater than half-dose. A total of 1500 randomized patients provide 90% power to detect a hazard ratio of 0.5, over an average follow-up of 3 years, according to a total primary event rate (any stroke) of 12% in the control arm and other assumptions. Secondary outcomes include recurrent ICH, cardiovascular events, and safety. Results: Recruitment started 28 September 2017. Up to 31 October 2021, 821 patients were randomized at 54 active sites in 10 countries. Triple Pill adherence after 30 months is 86%. The required sample size should be achieved by 2024. Conclusion: Low-dose Triple Pill BP lowering could improve long-term outcome from ICH.
KW - blood pressure lowering
KW - clinical trial
KW - Hypertension
KW - intracerebral hemorrhage
KW - outcomes
UR - http://www.scopus.com/inward/record.url?scp=85122729226&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1149987
UR - http://purl.org/au-research/grants/NHMRC/1103886
U2 - 10.1177/17474930211068671
DO - 10.1177/17474930211068671
M3 - Article
SN - 1747-4949
VL - 17
SP - 1156
EP - 1162
JO - International Journal of Stroke
JF - International Journal of Stroke
IS - 10
ER -