NCT02648464

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3.9 years

First QC Date

December 18, 2015

Last Update Submit

June 6, 2020

Conditions

Myocardial InfarctionAcute Coronary SyndromeInflammationHydroxychloroquineAntirheumatic AgentsCardiovascular Diseases

Keywords

Hydroxychloroquineanti-inflammatoryMyocardial infarctioncardiovascular diseases

Outcome Measures

Primary Outcomes (1)

  • Rate of major cardiovascular adverse events

    Myocardial infarction, mortality, hospitalization for unstable angina, and heart failure

    Twelve months

Secondary Outcomes (6)

  • Rate of the primary endpoint plus stroke and urgent coronary revascularization

    Twelve months

  • Effect on the incidence of type 2 diabetes and the level of Hba1c

    Six months

  • Effect on cholesterol levels

    Six months

  • Effect on high-sensitivity C-reactive protein (hs-CRP) level

    Six months

  • Effect on soluble biomarkers of inflammation

    Six months

  • +1 more secondary outcomes

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine 300 mg tablet by mouth daily for 6 months. Patients under the weight of 60 kg: hydroxychloroquine 300 mg tablet daily for 5 days per week for 6 months.

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Placebo tablet by mouth daily for 6 months. Patients under the weight of 60 kg: placebo tablet daily for 5 days per week for 6 months.

Drug: Placebo

Interventions

HydroxychloroquineDRUG
Also known as: Oxiklorin
Hydroxychloroquine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have high-sensitivity troponin or CKMB above the upper limit of normal with at least one of the following criteria:
  • Anginal symptoms suggestive of cardiac ischemia
  • Accelerating pattern of anginal pain (episodes of angina that have at least 5 minutes duration and are more frequent, severe, longer in duration and/or precipitated by less exertion).
  • Prolonged (\>20 minutes) or recurrent anginal pain at rest or with minimal effort.
  • Anginal pain at rest or with minimal exertion, and at least 20 minutes of duration, occurring \>48 hours after an acute Q-wave myocardial infarction.
  • ECG criteria
  • New, persistent or transient ST-segment depression \>0,1 mV (0,08 seconds after the J-point) in at least 2 extremity leads or 3 precordial leads.
  • New, persistent or transient ST-segment elevation in two contiguous leads ≥0.2 mV in men or ≥0.15 mV in women in leads V2-V3, and/or ≥0.1 mV in other leads.
  • Patients will be enrolled within 96 hours of coronary angiography

You may not qualify if:

  • Contraindication for hydroxychloroquine (porphyria, psoriasis, retinopathy, hypersensitivity)
  • Rheumatoid arthritis or other rheumatic disease
  • Significant neuropathy of any cause
  • Cardiomyopathy (diagnosed before the onset of index hospitalization)
  • Muscle disease (that could worsen by the use of hydroxychloroquine)
  • Pregnant or nursing women, and women of childbearing potential without efficient contraceptives.
  • Angina precipitated by obvious provoking factors
  • Prolonged ECG's corrected QT interval (\>480 ms)
  • Ongoing antibiotic therapy of any duration
  • Uncontrolled severe cardiac arrhythmia resulting in hemodynamic instability
  • Severe hepatic failure (alanine transaminase or gamma-glutamyltransferase ≥2 times above normal limits or international normalized ratio (INR) \>1,5 and patient not using warfarin, and due to other than cardiac reasons).
  • Renal failure, glomerular filtration rate \<50 ml/min/1,73m2
  • Hemoglobin \<100 g/l (if not possible to correct with transfusion)
  • Planned percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
  • Index myocardial infarction due to PCI or CABG restenosis.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Helsinki University Central Hospital

Helsinki, 00290, Finland

Location

North Karelia Central Hospital

Joensuu, Finland

Location

Kymenlaakso Central Hospital

Kotka, Finland

Location

Päijät-Häme Central Hospital

Lahti, Finland

Location

South Karelia Central Hospital

Lappeenranta, Finland

Location

South Ostrobotnia Central Hospital

Seinäjoki, Finland

Location

Related Publications (3)

  • Hartman O, Kovanen PT, Lehtonen J, Eklund KK, Sinisalo J. Hydroxychloroquine for the prevention of recurrent cardiovascular events in myocardial infarction patients: rationale and design of the OXI trial. Eur Heart J Cardiovasc Pharmacother. 2017 Apr 1;3(2):92-97. doi: 10.1093/ehjcvp/pvw035.

    PMID: 28025216BACKGROUND

  • Simonen P, Ulander L, Eklund KK, Niemi M, Backman JT, Gylling H, Sinisalo J; OXI pilot trial. The effect of hydroxychloroquine on cholesterol synthesis depends on the profile of cholesterol metabolism. A controlled clinical study. Atheroscler Plus. 2024 Mar 1;55:93-97. doi: 10.1016/j.athplu.2024.02.002. eCollection 2024 Mar.

    PMID: 38487037DERIVED

  • Ulander L, Simonen P, Tolppanen H, Hartman O, Rissanen TT, Eklund KK, Kalaoja M, Kurkela M, Neuvonen M, Niemi M, Backman JT, Gylling H, Sinisalo J; OXI pilot trial. The effect of hydroxychloroquine on cholesterol metabolism in statin treated patients after myocardial infarction. Atheroscler Plus. 2023 Jun 26;53:26-32. doi: 10.1016/j.athplu.2023.06.003. eCollection 2023 Sep.

    PMID: 37448694DERIVED

MeSH Terms

Conditions

Myocardial InfarctionAcute Coronary SyndromeInflammationCardiovascular Diseases

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Juha Sinisalo, Professor

    Helsinki University Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 18, 2015

First Posted

January 7, 2016

Study Start

February 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

Study data is planned to be available at the study organization´s website, and by specific request from the investigator

Locations

FI(6)