What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Acute spontaneous intracerebral hemorrhage. Intervention: Blood pressure lowering therapy. Primary outcome: Time to first recurrent stroke of any type.

What question did this study set out to answer?

To determine the efficacy of blood pressure lowering for secondary prevention of major cardiovascular events in patients with a history of intracerebral hemorrhage.

May 27, 2026

Blood pressure lowering for the prevention of REcurrent stroke and Cardiovascular outcomes After acute intracerebral haemorrhage: protocol for an individual Participant data meta-analysis of randomised controlled trials (RECAP-ICH)

Key Result

This protocol outlines an individual participant data meta-analysis to determine the efficacy of blood pressure lowering for secondary prevention after intracerebral hemorrhage.

Key Points

To determine the efficacy of blood pressure lowering for secondary prevention of major cardiovascular events in patients with a history of intracerebral hemorrhage.
Conducted a systematic review per PRISMA-IPD guidelines.
Searched multiple databases for randomized controlled trials with at least 100 patients with ICH.
Planned an individual participant data meta-analysis using major RCTs including TRIDENT, ESPRIT, PROGRESS, and RESPECT.
Primary outcome is time to first recurrent stroke; secondary outcomes include major adverse cardiovascular events such as non-fatal stroke and myocardial infarction.
Utilizing a Cox proportional hazards model for analysis, adjusting for important factors like age, hypertension, and diabetes.
Sensitivity analyses will address death as a competing risk to better understand the benefits over time.

Study Design

Type

Meta-Analysis

Multicenter

Yes

Structured PICO

Does blood pressure-lowering therapy reduce the risk of recurrent stroke and major cardiovascular events in patients with a history of intracerebral hemorrhage?

Population

Patients with a history of acute spontaneous intracerebral hemorrhage (ICH) from randomized controlled trials that enrolled at least 100 participants with ICH.

Intervention

Blood pressure-lowering therapy for secondary prevention.

Comparator

Control groups from the included randomized controlled trials.

Outcome

Time to first recurrent stroke of any type.hard clinical

This protocol outlines a planned individual participant data meta-analysis to determine the efficacy, optimal timing, and subgroup variations of blood pressure-lowering therapy for secondary prevention after intracerebral hemorrhage.

Abstract

Introduction: The benefits of long-term blood pressure (BP) lowering for the prevention of recurrent stroke and other serious cardiovascular (CV) events in patients who suffer an acute spontaneous intracerebral hemorrhage (ICH) is well established. However, there is uncertainty as to whether the treatment effect varies according to certain patient characteristics and across various CV and non-CV outcomes, and the timing of when the benefits manifest over time. We aim to pool individual participant data (IPD) from randomised controlled trials (RCTs) that included patients with a history of ICH to determine the efficacy of BP lowering for the secondary prevention of major CV events. Methods and analysis: A systematic review was undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (PRISMA-IPD) Statement. A search of multiple databases from inception to 25 January 2026 was conducted to identify RCTs of BP-lowering therapy for secondary prevention after ICH that enrolled at least 100 participants with ICH. We will undertake an IPD meta-analysis, with TRIDENT (Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial) serving as our anchor study, and three other major RCTs of BP lowering treatment for secondary prevention with a subgroup of at least 100 ICH patients: ESPRIT (Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing Risk of Vascular Events) trial, PROGRESS (Perindopril Protection Against Recurrent Stroke Study), and RESPECT (Recurrent Stroke Prevention Clinical Outcome) Study. The primary CV outcome is the time to first recurrent stroke of any type. Secondary outcomes include major adverse cardiovascular events (MACE): non-fatal stroke, non-fatal myocardial infarction, or cardiovascular death; each component of MACE, stroke subtypes, and all-cause death. The safety outcome is any serious adverse event. All analyses will be performed on the intention-to-treat dataset from each trial using a one-stage approach. The effect of the intervention will be estimated as the cause-specific hazard ratio and 95% confidence intervals (CI) obtained from a Cox proportional hazard model, adjusting for age, sex, history of hypertension, and history of diabetes mellitus. A sensitivity analysis will treat death as a competing risk. The time to benefit of BP lowering will also be estimated according to specific absolute risk reduction thresholds.

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