NCT03209258: INTERACT3

The Third, Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial

Completed NA Last updated 29 November 2022

What this trial tests

NA trial testing Care bundle of active management in Cerebral Hemorrhage in 7,067 participants. Completed in 17 November 2022.

Timeline

12 December 2017

Primary endpoint
12 October 2022

17 November 2022

Quick facts

Lead sponsor	The George Institute for Global Health, China
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	treatment
Enrollment	7,067
Start date	12 December 2017
Primary completion	12 October 2022
Estimated completion	17 November 2022
Sites	1 location across China

Drugs / interventions tested

• Care bundle of active management
• Usual care

Conditions studied

• Cerebral Hemorrhage — all drugs for Cerebral Hemorrhage →
• Stroke — all drugs for Stroke →
• Hypertension — all drugs for Hypertension →
• Diabetes — all drugs for Diabetes →

Sponsor

The George Institute for Global Health, China

Who can join

18 and older, any sex, with Cerebral Hemorrhage or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Continued uncertainty exists over benefits of early intensive blood pressure (BP) lowering in acute intracerebral hemorrhage (ICH), related to the non-significant primary outcomes, patient selection, and discordant results of INTERACT2 and ATACH-II. We designed INTERACT3 to determine the effectiveness of a goal-directed care bundle of active management (intensive BP lowering, glycemic control, treatment of pyrexia and reversal of anticoagulation) vs. usual care in ICH.

INTERACT3 is a large-scale pragmatic clinical trial to provide reliable evidence over the effectiveness of a widely applicable goal-directed care bundle in acute ICH.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial.
   Ma L, Hu X, Song L, Chen X, et al · · 2023 · cited 254× · PMID 37245517 · DOI 10.1016/s0140-6736(23)00806-1
2. INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial.
   Song L, Hu X, Ma L, Chen X, et al · · 2021 · cited 19× · PMID 34930428 · DOI 10.1186/s13063-021-05881-7
3. Impact of COVID-2019 on stroke services in China: survey from the Chinese Stroke Association.
   Wang X, Ouyang M, Carcel C, Chen C, et al · · 2020 · cited 18× · PMID 32989012 · DOI 10.1136/svn-2020-000514
4. Association of Intraventricular Fibrinolysis With Clinical Outcomes in Intracerebral Hemorrhage: An Individual Participant Data Meta-Analysis.
   Kuramatsu JB, Gerner ST, Ziai W, Bardutzky J, et al · · 2022 · cited 15× · PMID 35521958 · DOI 10.1161/strokeaha.121.038455
5. Effects of blood pressure lowering in relation to time in acute intracerebral haemorrhage: a pooled analysis of the four INTERACT trials.
   Wang X, Ren X, Li Q, Ouyang M, et al · · 2025 · cited 13× · PMID 40541207 · DOI 10.1016/s1474-4422(25)00160-7
6. 11th European Stroke Organisation Conference Abstracts - 21-23 May 2025, Helsinki, Finland.
   · 2025 · cited 3× · PMID 40726475 · DOI 10.1177/23969873251329993
7. Statistical Analysis Plan for the INTEnsive Care Bundle with Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial: A Stepped-Wedge Cluster Randomized Controlled Trial.
   Billot L, Song L, Hu X, Ma L, et al · · 2023 · cited 3× · PMID 36063792 · DOI 10.1159/000526384
8. Process Evaluation of an Implementation Trial: Design, Rationale, and Early Lessons Learnt From an International Cluster Clinical Trial in Intracerebral Hemorrhage.
   Ouyang M, Anderson CS, Song L, Malavera A, et al · · 2022 · cited 2× · PMID 35783649 · DOI 10.3389/fmed.2022.813749