What is the clinical evidence from this study?

Study design: RCT. Population: Stable ischaemic heart disease and acute coronary syndromes (n=57). Intervention: Interleukin-2 (aldesleukin) vs. Placebo. Primary outcome: Safety and tolerability, and determination of the dose that increases mean circulating Treg levels by at least 75%.

September 1, 2018BMJ OpenOpen Access

Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase I/II clinical trial

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Key result

Low-dose interleukin-2 (aldesleukin) will be evaluated for safety, tolerability, and its ability to increase regulatory T cells in patients with stable ischaemic heart disease and acute coronary syndromes.

Why the study?

Does low-dose interleukin-2 (aldesleukin) safely increase regulatory T cell levels in patients with stable ischaemic heart disease and acute coronary syndromes?

Study Design

Type

RCT (n=57)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Structured PICO

Does low-dose interleukin-2 (aldesleukin) safely increase regulatory T cell levels in patients with stable ischaemic heart disease and acute coronary syndromes?

Population

57 patients with stable ischaemic heart disease or acute coronary syndromes to be enrolled in a phase I/II dose-escalation trial to evaluate low-dose interleukin-2.

Intervention

Low-dose interleukin-2 (aldesleukin; dose range 0.3-3x10^6 IU) once daily, given subcutaneously, for five consecutive days

Comparator

Placebo once daily, given subcutaneously, for five consecutive days

Outcome

Safety and tolerability of aldesleukin and determination of the dose that increases mean circulating Treg levels by at least 75%safety

This protocol outlines a phase I/II trial to evaluate the safety, tolerability, and Treg-enhancing dose of low-dose interleukin-2 in patients with stable ischemic heart disease and acute coronary syndromes.

Limitations

Due to its early phase design, this study is not powered to assess any clinical outcome data for patients.

Authors

TZTian ZhaoMerck & Co., Inc., Rahway, NJ, USA (United States)CGCharmaine GriffithsUniversity College London EAEmma L ArbonUniversity of Cambridge

Discussion

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Implication

Phase I/II RCT will test low-dose IL-2 safety and Treg dosing in IHD/ACS; leaves open clinical efficacy.

Cite This Study

Zhao et al. (2018) conducted an RCT in Stable ischaemic heart disease and acute coronary syndromes (n=57). Interleukin-2 (aldesleukin) vs. Placebo was evaluated on Safety and tolerability, and determination of the dose that increases mean circulating Treg levels by at least 75%. Low-dose interleukin-2 (aldesleukin) will be evaluated for safety, tolerability, and its ability to increase regulatory T cells in patients with stable ischaemic heart disease and acute coronary syndromes.

synapsesocial.com/papers/6a9cd8473a585fe6897be3e1 https://doi.org/10.1136/bmjopen-2018-022452

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Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase I/II clinical trial

Study Design

Structured PICO

Limitations

Discussion

Implication

Cite This Study

Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase I/II clinical trial

Study Design

Structured PICO

Limitations

Discussion

Implication

Cite This Study

Also Consider

Also Consider