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Myocardial InfarctionPhase 4OXINCT02648464

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

A Phase 4 study testing Hydroxychloroquine in people with Myocardial Infarction and Acute Coronary Syndrome, run by Helsinki University Central Hospital at 6 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Hydroxychloroquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
6 sitesFinland
Study dates
1 Feb 2016to 31 Dec 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.
  • Inability to interpret ST-T segment changes on ECG (e.g. complete left bundle branch block or paced rhythm)
  • Prior thrombolytic therapy (within 12 hours)
  • Inability to give informed consent
  • Fulminant vomiting or other disability to give oral medication
  • Over 80 years of age
  • Life expectancy less than one year
  • Receiving another investigational drug within 4 weeks prior to the study. (Patients who have participated in investigational trials before the 4-week time period may be randomized as long as they have reached the primary endpoint).
  • Patients with any other medical condition which, in the investigator's opinion, would interfere with optimal participation in the study or produce a significant risk to the patient
  • In addition, patients are not eligible for the PET/CT subgroup if they have received statin-therapy in the last 2 months prior to the hospitalization (i.e. statin therapy started during the index hospitalization is not an exclusion criteria).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Finland6 sites

  • Helsinki University Central Hospital

    Helsinki, 00290

  • North Karelia Central Hospital

    Joensuu

  • Kymenlaakso Central Hospital

    Kotka

  • Päijät-Häme Central Hospital

    Lahti

  • South Karelia Central Hospital

    Lappeenranta

  • South Ostrobotnia Central Hospital

    Seinäjoki

Other trials in Finland

About this study

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

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.

Read the detailed description

Anti-rheumatic medications decrease cardiovascular mortality in rheumatoid arthritis patients, based mainly on their anti-inflammatory effect. No studies have addressed their effect on preventing recurrent cardiovascular events among non-rheumatic patients.

In the pilot phase 200 myocardial infarction patients will be recruited during their index visit to the study hospitals. Patients will be randomized after initial coronary angiography to receive either hydroxychloroquine 300 mg a day or placebo during six months. Patients will be followed up until 12 months at four visits. Visit one is at doctor´s office at 3 to 5 weeks from the day of recruitment. Visit two is at study nurse´s office at 5.5 to 6 months. Visit three is a phone interview by the study nurse at 8.5 to 9.5 months. Visit four at 11.5 to 12.5 months is at doctor´s office.

This study evaluates the safety of hydroxychloroquine in the setting of myocardial infarction, and whether hydroxychloroquine treatment could reduce the incidence of recurrent cardiovascular events among myocardial infarction patients. Furthermore, the effect of hydroxychloroquine on cardiovascular risk factors and systemic inflammation parameters will be studied. In a subgroup of 40 patients, the effect of hydroxychloroquine on aortic inflammation will be assessed by PET/CT scan.

If this safety pilot study with 200 patients proves successful (i.e. no major complications), 2500 patients will be recruited in additional centers in Finland and the Nordic Countries.

Orion Pharma provides the active hydroxychloroquine tablet (Oxiklorin) but provides no other assistance or funding for the study.

Being tested
Hydroxychloroquine, Placebo
Keywords
Hydroxychloroquine, anti-inflammatory, Myocardial infarction, cardiovascular diseases
Medical subject headings
Myocardial Infarction, Acute Coronary Syndrome, Inflammation, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02648464
Study groupRoleWhat they receive
HydroxychloroquineExperimentalHydroxychloroquine 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.
Receives: Drug: Hydroxychloroquine
PlaceboPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of major cardiovascular adverse events

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

    Measured: Twelve months

Secondary outcomes (6)

  1. Rate of the primary endpoint plus stroke and urgent coronary revascularization

    Measured: Twelve months

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

    Measured: Six months

  3. Effect on cholesterol levels

    The effect of hydroxychloroquine on total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglyceride levels

    Measured: Six months

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

    Measured: Six months

  5. Effect on soluble biomarkers of inflammation

    Frozen samples (plasma and whole blood) will be stored for future evaluation of biomarkers related to inflammation and cardiovascular disease, such as tumor necrosis factor alpha, interleukin 6 (IL-6), IL-1beta, IL-18, and messenger ribonucleic acid (mRNA) analyses.

    Measured: Six months

  6. Effect on aortic inflammation assessed by PET / CT scan

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2016 (estimated)
  2. Study start1 Feb 2016
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02648464
Sponsor's protocol ID
2015-000233-73
Other IDs
2015
Acronym
OXI
Status last verified
Jun 2020
First submitted
18 Dec 2015
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Study data is planned to be available at the study organization´s website, and by specific request from the investigator

Publications

  • 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.

    PubMed 28025216

  • 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.

    PubMed 38487037

  • 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.

    PubMed 37448694

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hydroxychloroquine in people with Myocardial Infarction and Acute Coronary Syndrome, run by Helsinki University Central Hospital at 6 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of major cardiovascular adverse events (time frame: Twelve months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02648464, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.

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