ST Segment Elevation Myocardial InfarctionPhase 2NCT03508232
Doxycycline to Protect Heart Muscle After Heart Attacks
A Phase 2 study testing Doxycycline Hyclate in people with ST Segment Elevation Myocardial Infarction and Heart Failure, run by University of Alberta at 1 site in Canada.
Trial summary
Current medical treatment allows more people to survive heart attacks than in the past. However, some of the survivors suffer heart disease and require hospitalization later on. The causes behind this heart disease (heart failure) after a heart attack are poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction, Heart Failure
- What is being tested?
- Doxycycline Hyclate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2020to 26 Aug 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ year old
- Diagnosis of acute ST-elevation myocardial infarction (STEMI)
- Primary STEMI
- Symptom onset of less than 12 hours
- Admitted to the Royal Alexandra Hospital in Edmonton, Alberta
Who cannot join
- Low risk inferior STEMI (total ST elevation plus depression <4mm)
- Cardiogenic shock
- Use of thrombolytics
- Prior history of myocardial infarction or heart failure
- Known hypersensitivity to tetracyclines
- Any concurrent medical condition expected to reduce life expectancy to <1 year
- Symptom onset to treatment (loading dose) time longer than 24 hours
- Poor renal function (eGFR<30 mL/min/1.73m2) or other contraindications to MRI (claustrophobia, pregnancy, PPM/ICD, sub-arachnoid clips, retained ocular foreign body)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Matrix Metalloproteinase Inhibition With Doxycycline to Prevent Adverse Remodeling After Acute Myocardial Infarction: A Pilot Study
Current medical treatment allows more people to survive heart attacks than in the past. However, some of the survivors suffer heart disease and require hospitalization later on. The causes behind this heart disease (heart failure) after a heart attack are poorly understood.
Matrix metalloproteinase 2 (MMP-2) is a protein that cuts other proteins into pieces, and is activated in heart muscle when there is a heart attack. MMP-2 causes heart injury when the blood flow to the heart is restored after the attack. Blocking MMP-2 activity is a potential therapy to prevent heart injury under these circumstances. The only MMP-2 inhibiting drug currently approved for clinical use is doxycycline, specifically used to treat periodontitis (gum inflammation) and rosacea (a skin condition). At higher doses doxycycline also acts as an antibiotic for which it has been clinically used for decades.
Read more
A previous clinical study found that taking doxycycline twice a day, for one week after a heart attack improved the health of the patients' hearts. The investigators have conducted a similar study in patients that had surgery to replace blocked coronary arteries (blood vessels that feed the heart muscle). These patients took a low dose of doxycycline once a day for 2 days before surgery, on the day of the surgery, and three days after surgery. The participants in this study showed no adverse effects of using doxycycline.
The goal of this study is to see if doxycycline protects the hearts of patients that suffered a heart attack. All patients will receive standard clinical care for their condition, but in addition will take a doxycycline capsule twice a day, or a placebo capsule for 7 days, as soon as possible after being diagnosed with a heart attack. Three months later, the investigators will evaluate the patients by looking at their heart structure using magnetic resonance imaging (MRI). MRI is a powerful tool that allows doctors to see inside the body without surgery or X-ray radiation. The hearts of those patients that received doxycycline are expected to be healthier than those who received placebo.
The investigators plan to promote the use of doxycycline to protect the hearts of patients with heart attacks. If successful, doxycycline could help improve the quality of life of heart attack survivors.
Read the detailed description
Background:
Matrix metalloproteinases (MMPs) are activated in myocardial ischemia, digesting key structural components in cardiac muscle in the setting of myocardial infarction and myocardial ischemia-reperfusion injury (Schulz, 2007, Annu. Rev. Pharmacol. Toxicol. 47, 211-42).
The antibiotic doxycycline is the only drug approved as an MMP inhibitor by Health Canada and the U.S. FDA for the treatment of periodontitis and rosacea at sub-antimicrobial doses.
Doxycycline decreases intracellular proteolysis, improves cardiac function, and reduces infarct size in animal models of ischemia-reperfusion injury (Cheung et al, 2002, Circulation 101:1833-39; Villarreal et al, 2003, Circulation 208:1487-92).
TIPTOP (Cerisano et al, 2014, Eur Heart J 35: 184-91) was a randomized open-label trial (110 patients) that studied the effect of 1-week doxycycline given post-percutaneous coronary intervention (PCI) in patients with anterior STEMI. Patients who received doxycycline showed improved echocardiographic indices at 6 months relative to untreated controls: left ventricular end diastolic volume index (LVEDVi) -8 mL ± 14 mL (P=0.004), left ventricular end systolic volume index (LVESVi) -6 mL ± 12 mL (P=0.02), and left ventricular ejection fraction (LVEF) +5% ± 12% (P=0.04). They also showed decreased infarct sizes (-6%, P=0.05) by single photon emission computed tomography (SPECT).
Rationale for study:
The TIPTOP pilot study showed promise for doxycycline therapy to decrease adverse ventricular remodeling post-PCI in STEMI patients. Animal models suggest that MMP activation occurs early in reperfusion (within 5 minutes) following severe ischemia, and the TIPTOP pilot showed that early treatment may result in measurable clinical benefit. However, the TIPTOP pilot was an open label study and used a low resolution approach to measure clinical outcomes.
This is a small-scale, single-centre Phase II trial with double blinding, and includes the use of magnetic resonance imaging to measure primary (LVESVi) and secondary outcomes (LVEF ad LVEDVi). The investigators anticipate beneficial effects of doxycycline, with patients showing lower levels of LVESVi and LVEDVi, increased LVEF by MRI, and reduced infarct sizes, compared to placebo at 3 months. The investigators also expect hospitalization and mortality rates due to cardiac events to be reduced in these patients.
If successful, the overarching goal is to develop a multi-center randomized, blinded, placebo-controlled trial to examine the effect of early doxycycline therapy in the setting of STEMI.
- Being tested
- Placebo, Doxycycline Hyclate
- Medical subject headings
- ST Elevation Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Patients will receive placebo in a loading dose of two capsules initially followed by one capsule every 12 hours for 7 days.
Doxycycline HyclateDrug
Also called Doxycycline
Patients will receive doxycycline hyclate in a loading dose of two 100 mg capsules (200 mg total) initially followed by one 100 mg capsule every 12 hours for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Placebo comparator | Two placebo capsules upon enrollment, followed by one placebo capsule p.o. every 12 hours for 7 days Receives: Drug: Doxycycline Hyclate |
| Doxycycline hyclate | Experimental | Two 100mg doxycycline capsules (200 mg) p.o. upon enrollment, followed by one 100 mg capsule p.o. every 12 hours for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular end-systolic volume index (LVESVi)
Left ventricular end-systolic volume index (LVESVi) measured by magnetic resonance imaging (MRI) at 3 months post intervention
Measured: 3 months post intervention
Secondary outcomes (4)
Composite endpoint of mortality and hospital admission due to re-infarction, heart failure, or stroke
Composite endpoint of mortality and hospital admission due to re-infarction, heart failure, or stroke at 3 months and 1 year.
Measured: 3 months and one year post intervention
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) by cardiac MRI and echocardiography during hospital admission and at 3-month follow-up.
Measured: 3 months post intervention
Left ventricular end-diastolic volume index (LVEDVi)
Left ventricular end-diastolic volume index (LVEDVi) by cardiac MRI and echocardiography during hospital admission and at 3-month follow-up.
Measured: 3 months post intervention
Infarct size
Infarct size by cardiac MRI during hospital admission and at 3-month follow-up
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start6 Jan 2020
- Primary completion26 Jul 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Alexandra Hospital
- Responsible party
- Sponsor
- Investigators
- Richard Schulz, PhD, Study chair, Dept. of Pediatrics and Pharmacology, University of AlbertaPeter Hwang, MD, PhD, Study director, Dept. of Medicine, University of AlbertaBenjamin Tyrrell, MD, Study director, Dept. of Medicine, University of AlbertaRichard Coulden, MD, Principal investigator, Dept. of Radiology and Diagnostic Imaging, University of AlbertaNeil Brass, MD, Principal investigator, Dept. of Medicine, University of AlbertaRaymond Leung, MD, Principal investigator, CK Hui Heart Centre, Royal Alexandra Hospital, Edmonton, Alberta.Kevin Bainey, MD, Principal investigator, Dept. of Medicine, University of AlbertaRichard Thompson, MD, Principal investigator, Dept. of Biomedical Engineering, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508232
- Sponsor's protocol ID
- DOXY-STEMI
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schulz R. Intracellular targets of matrix metalloproteinase-2 in cardiac disease: rationale and therapeutic approaches. Annu Rev Pharmacol Toxicol. 2007;47:211-42. doi: 10.1146/annurev.pharmtox.47.120505.105230.
PubMed 17129183Cheung PY, Sawicki G, Wozniak M, Wang W, Radomski MW, Schulz R. Matrix metalloproteinase-2 contributes to ischemia-reperfusion injury in the heart. Circulation. 2000 Apr 18;101(15):1833-9. doi: 10.1161/01.cir.101.15.1833.
PubMed 10769285Villarreal FJ, Griffin M, Omens J, Dillmann W, Nguyen J, Covell J. Early short-term treatment with doxycycline modulates postinfarction left ventricular remodeling. Circulation. 2003 Sep 23;108(12):1487-92. doi: 10.1161/01.CIR.0000089090.05757.34. Epub 2003 Sep 2.
PubMed 12952845Schulze CJ, Castro MM, Kandasamy AD, Cena J, Bryden C, Wang SH, Koshal A, Tsuyuki RT, Finegan BA, Schulz R. Doxycycline reduces cardiac matrix metalloproteinase-2 activity but does not ameliorate myocardial dysfunction during reperfusion in coronary artery bypass patients undergoing cardiopulmonary bypass. Crit Care Med. 2013 Nov;41(11):2512-20. doi: 10.1097/CCM.0b013e318292373c.
PubMed 23928836Cerisano G, Buonamici P, Valenti R, Sciagra R, Raspanti S, Santini A, Carrabba N, Dovellini EV, Romito R, Pupi A, Colonna P, Antoniucci D. Early short-term doxycycline therapy in patients with acute myocardial infarction and left ventricular dysfunction to prevent the ominous progression to adverse remodelling: the TIPTOP trial. Eur Heart J. 2014 Jan;35(3):184-91. doi: 10.1093/eurheartj/eht420. Epub 2013 Oct 8.
PubMed 24104875
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matrix Metalloproteinase Inhibition With Doxycycline to Prevent Adverse Remodeling After Acute Myocardial Infarction: A Pilot Study
- ClinicalTrials.gov ID
- NCT03508232
- Acronym / sponsor ID
- DOXY-STEMI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Royal Alexandra Hospital
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 26 Jul 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current medical treatment allows more people to survive heart attacks than in the past. However, some of the survivors suffer heart disease and require hospitalization later on. The causes behind this heart disease (heart failure) after a heart attack are poorly understood.
Matrix metalloproteinase 2 (MMP-2) is a protein that cuts other proteins into pieces, and is activated in heart muscle when there is a heart attack. MMP-2 causes heart injury when the blood flow to the heart is restored after the attack. Blocking MMP-2 activity is a potential therapy to prevent heart injury under these circumstances. The only MMP-2 inhibiting drug currently approved for clinical use is doxycycline, specifically used to treat periodontitis (gum inflammation) and rosacea (a skin condition). At higher doses doxycycline also acts as an antibiotic for which it has been clinically used for decades.
A previous clinical study found that taking doxycycline twice a day, for one week after a heart attack improved the health of the patients' hearts. The investigators have conducted a similar study in patients that had surgery to replace blocked coronary arteries (blood vessels that feed the heart muscle). These patients took a low dose of doxycycline once a day for 2 days before surgery, on the day of the surgery, and three days after surgery. The participants in this study showed no adverse effects of using doxycycline.
The goal of this study is to see if doxycycline protects the hearts of patients that suffered a heart attack. All patients will receive standard clinical care for their condition, but in addition will take a doxycycline capsule twice a day, or a placebo capsule for 7 days, as soon as possible after being diagnosed with a heart attack. Three months later, the investigators will evaluate the patients by looking at their heart structure using magnetic resonance imaging (MRI). MRI is a powerful tool that allows doctors to see inside the body without surgery or X-ray radiation. The hearts of those patients that received doxycycline are expected to be healthier than those who received placebo.
The investigators plan to promote the use of doxycycline to protect the hearts of patients with heart attacks. If successful, doxycycline could help improve the quality of life of heart attack survivors.
Detailed description
Background:
Matrix metalloproteinases (MMPs) are activated in myocardial ischemia, digesting key structural components in cardiac muscle in the setting of myocardial infarction and myocardial ischemia-reperfusion injury (Schulz, 2007, Annu. Rev. Pharmacol. Toxicol. 47, 211-42).
The antibiotic doxycycline is the only drug approved as an MMP inhibitor by Health Canada and the U.S. FDA for the treatment of periodontitis and rosacea at sub-antimicrobial doses.
Doxycycline decreases intracellular proteolysis, improves cardiac function, and reduces infarct size in animal models of ischemia-reperfusion injury (Cheung et al, 2002, Circulation 101:1833-39; Villarreal et al, 2003, Circulation 208:1487-92).
TIPTOP (Cerisano et al, 2014, Eur Heart J 35: 184-91) was a randomized open-label trial (110 patients) that studied the effect of 1-week doxycycline given post-percutaneous coronary intervention (PCI) in patients with anterior STEMI. Patients who received doxycycline showed improved echocardiographic indices at 6 months relative to untreated controls: left ventricular end diastolic volume index (LVEDVi) -8 mL ± 14 mL (P=0.004), left ventricular end systolic volume index (LVESVi) -6 mL ± 12 mL (P=0.02), and left ventricular ejection fraction (LVEF) +5% ± 12% (P=0.04). They also showed decreased infarct sizes (-6%, P=0.05) by single photon emission computed tomography (SPECT).
Rationale for study:
The TIPTOP pilot study showed promise for doxycycline therapy to decrease adverse ventricular remodeling post-PCI in STEMI patients. Animal models suggest that MMP activation occurs early in reperfusion (within 5 minutes) following severe ischemia, and the TIPTOP pilot showed that early treatment may result in measurable clinical benefit. However, the TIPTOP pilot was an open label study and used a low resolution approach to measure clinical outcomes.
This is a small-scale, single-centre Phase II trial with double blinding, and includes the use of magnetic resonance imaging to measure primary (LVESVi) and secondary outcomes (LVEF ad LVEDVi). The investigators anticipate beneficial effects of doxycycline, with patients showing lower levels of LVESVi and LVEDVi, increased LVEF by MRI, and reduced infarct sizes, compared to placebo at 3 months. The investigators also expect hospitalization and mortality rates due to cardiac events to be reduced in these patients.
If successful, the overarching goal is to develop a multi-center randomized, blinded, placebo-controlled trial to examine the effect of early doxycycline therapy in the setting of STEMI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Placebo comparator | Drug: Doxycycline HyclateTwo placebo capsules upon enrollment, followed by one placebo capsule p.o. every 12 hours for 7 days |
| Doxycycline hyclate | Experimental | Drug: PlaceboTwo 100mg doxycycline capsules (200 mg) p.o. upon enrollment, followed by one 100 mg capsule p.o. every 12 hours for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18+ year old
- Diagnosis of acute ST-elevation myocardial infarction (STEMI)
- Primary STEMI
- Symptom onset of less than 12 hours
- Admitted to the Royal Alexandra Hospital in Edmonton, Alberta
Key exclusion criteria (8 listed)
- Low risk inferior STEMI (total ST elevation plus depression <4mm)
- Cardiogenic shock
- Use of thrombolytics
- Prior history of myocardial infarction or heart failure
- Known hypersensitivity to tetracyclines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPatients will receive placebo in a loading dose of two capsules initially followed by one capsule every 12 hours for 7 days. | Drug | Doxycycline hyclate |
| Doxycycline HyclateAlso: DoxycyclinePatients will receive doxycycline hyclate in a loading dose of two 100 mg capsules (200 mg total) initially followed by one 100 mg capsule every 12 hours for 7 days. | Drug | Placebo control |
Primary outcome
Left ventricular end-systolic volume index (LVESVi)
Time frame: 3 months post intervention
Left ventricular end-systolic volume index (LVESVi) measured by magnetic resonance imaging (MRI) at 3 months post intervention
4 secondary outcomes
Composite endpoint of mortality and hospital admission due to re-infarction, heart failure, or stroke
Time frame: 3 months and one year post intervention
Left ventricular ejection fraction (LVEF)
Time frame: 3 months post intervention
Left ventricular end-diastolic volume index (LVEDVi)
Time frame: 3 months post intervention
Infarct size
Time frame: 3 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 17129183Schulz R. Intracellular targets of matrix metalloproteinase-2 in cardiac disease: rationale and therapeutic approaches. Annu Rev Pharmacol Toxicol. 2007;47:211-42. doi: 10.1146/annurev.pharmtox.47.120505.105230.
- Background: PubMed 10769285Cheung PY, Sawicki G, Wozniak M, Wang W, Radomski MW, Schulz R. Matrix metalloproteinase-2 contributes to ischemia-reperfusion injury in the heart. Circulation. 2000 Apr 18;101(15):1833-9. doi: 10.1161/01.cir.101.15.1833.
- Background: PubMed 12952845Villarreal FJ, Griffin M, Omens J, Dillmann W, Nguyen J, Covell J. Early short-term treatment with doxycycline modulates postinfarction left ventricular remodeling. Circulation. 2003 Sep 23;108(12):1487-92. doi: 10.1161/01.CIR.0000089090.05757.34. Epub 2003 Sep 2.
- Background: PubMed 23928836Schulze CJ, Castro MM, Kandasamy AD, Cena J, Bryden C, Wang SH, Koshal A, Tsuyuki RT, Finegan BA, Schulz R. Doxycycline reduces cardiac matrix metalloproteinase-2 activity but does not ameliorate myocardial dysfunction during reperfusion in coronary artery bypass patients undergoing cardiopulmonary bypass. Crit Care Med. 2013 Nov;41(11):2512-20. doi: 10.1097/CCM.0b013e318292373c.
- Background: PubMed 24104875Cerisano G, Buonamici P, Valenti R, Sciagra R, Raspanti S, Santini A, Carrabba N, Dovellini EV, Romito R, Pupi A, Colonna P, Antoniucci D. Early short-term doxycycline therapy in patients with acute myocardial infarction and left ventricular dysfunction to prevent the ominous progression to adverse remodelling: the TIPTOP trial. Eur Heart J. 2014 Jan;35(3):184-91. doi: 10.1093/eurheartj/eht420. Epub 2013 Oct 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Schulz, PhD study chair
Dept. of Pediatrics and Pharmacology, University of Alberta
Peter Hwang, MD, PhD study director
Dept. of Medicine, University of Alberta
Benjamin Tyrrell, MD study director
Dept. of Medicine, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline Hyclate in people with ST Segment Elevation Myocardial Infarction and Heart Failure, run by University of Alberta at 1 site in Canada.
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 5 inclusion and 8 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Left ventricular end-systolic volume index (LVESVi) (time frame: 3 months post intervention). 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 NCT03508232, which also lists 5 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 13 Apr 2026.