NCT02648464: OXI

Hydroxychloroquine for the Prevention of Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial

Completed Phase 4 Last updated 9 June 2020

What this trial tests

Phase 4 trial testing Hydroxychloroquine in Myocardial Infarction in 125 participants. Completed in 31 December 2019.

Timeline

1 February 2016

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Helsinki University Central Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	125
Start date	1 February 2016
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	6 locations across Finland

Drugs / interventions tested

• Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
• Placebo

Conditions studied

• Myocardial Infarction — all drugs for Myocardial Infarction →
• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• Inflammation — all drugs for Inflammation →
• Hydroxychloroquine — all drugs for Hydroxychloroquine →

Sponsor

Helsinki University Central Hospital

Who can join

Adults 18 to 80, any sex, with Myocardial Infarction or Acute Coronary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This safety pilot study evaluates the effect of hydroxychloroquine on preventing recurrent cardiovascular events among myocardial infarction patients. Half of the participants will receive hydroxychloroquine, whereas the other half will receive placebo during six months.

Publications & conference data

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

1. Therapeutic strategies targeting inflammation and immunity in atherosclerosis: how to proceed?
   Engelen SE, Robinson AJB, Zurke YX, Monaco C. · · 2022 · cited 308× · PMID 35102320 · DOI 10.1038/s41569-021-00668-4
2. Macrophages in cardiovascular diseases: molecular mechanisms and therapeutic targets.
   Chen R, Zhang H, Tang B, Luo Y, et al · · 2024 · cited 169× · PMID 38816371 · DOI 10.1038/s41392-024-01840-1
3. Protective Effects of Hydroxychloroquine against Accelerated Atherosclerosis in Systemic Lupus Erythematosus.
   Floris A, Piga M, Mangoni AA, Bortoluzzi A, et al · · 2018 · cited 59× · PMID 29670462 · DOI 10.1155/2018/3424136
4. Atherosclerotic Cardiovascular Disease in Rheumatoid Arthritis: Impact of Inflammation and Antirheumatic Treatment.
   Kerola AM, Rollefstad S, Semb AG. · · 2021 · cited 43× · PMID 34040652 · DOI 10.15420/ecr.2020.44
5. T Cells in Autoimmunity-Associated Cardiovascular Diseases.
   Schwartz DM, Burma AM, Kitakule MM, Luo Y, et al · · 2020 · cited 38× · PMID 33117403 · DOI 10.3389/fimmu.2020.588776
6. Expanding horizons for clinical applications of chloroquine, hydroxychloroquine, and related structural analogues.
   Shukla AM, Wagle Shukla A. · · 2019 · cited 31× · PMID 31844421 · DOI 10.7573/dic.2019-9-1
7. Cardiovascular Impairment in COVID-19: Learning From Current Options for Cardiovascular Anti-Inflammatory Therapy.
   Wang L, Zhang Y, Zhang S. · · 2020 · cited 19× · PMID 32426374 · DOI 10.3389/fcvm.2020.00078
8. Cardiac macrophages in maintaining heart homeostasis and regulating ventricular remodeling of heart diseases.
   Kang M, Jia H, Feng M, Ren H, et al · · 2024 · cited 14× · PMID 39372400 · DOI 10.3389/fimmu.2024.1467089