Hepatitis C, ChronicNCT03423641

An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C

An observational study of Hepatitis C, Chronic, run by Kaiser Permanente.

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

Who is it for?: Ages 18 to 88 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Direct Acting Antivirals
How many people: 33,808 participants
Where: No sites listed yet
Study dates: 1 Jan 2011to 31 Dec 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 88 years
All sexes
Adult, Older adult

Study population: The groups/cohorts will consist of all HCV patients from Kaiser Permanente Southern California region, Kaiser Permanente Northern California region, and the OneFlorida Clinical Research Consortium.

Who may be able to join

HCV viral load
HCV genotype
HCV qualitative
HCV antibody
HCV drug
Continuously enrolled 12 months

Who cannot join

Each outcome will be analyzed separately as time to first event, thus people who experience an outcome prior to their study start date are ineligible for analyses related to that particular outcome.
The results will be examined for sensitivity to the following possible exclusion criteria:
Achieved SVR-12 prior to index date
HCV treatment experienced prior to index date
No visit in GI, Infectious Disease, or Liver Transplant / Hepatology
No positive HCV test (genotype, viral load, or qualitative)
No recent positive HCV test (genotype, viral load or qualitative)

About this study

Official title: Safety of Direct-Acting Antiviral Medications for Hepatitis C

The investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients with HCV who are untreated. The investigators hypothesize that patients receiving DAAs do not experience higher rates of adverse events compared to patients who have not received DAAs. The study population is adults between the ages of 18 and 88 with any indication of a diagnosis of HCV. An intervention group (those receiving a DAA) and comparison group (those who are not treated) will be created using medication dispensing data. Eligibility for the study will be determined from January 1, 2011 through December 31, 2017. Covariates will be collected from January 1, 2011 through December 31, 2017. Individual study sites may have access to historical data prior to 2011 that can be used as covariates or to identify individuals with HCV. The primary outcomes of interest include acute myocardial infarction, neurological outcomes (e.g. acute stroke, intracranial bleed), acute kidney failure, acute on chronic liver failure, hepatic decompensation, multiple organ dysfunction syndrome, cancer, bradyarrhythmia, and death. The secondary outcomes include decompensated cirrhosis, hospitalization, emergency department visit, and arrhythmia. Outcomes will be assessed from January 1, 2011 through December 31, 2017. The investigators will use two different analytic approaches to answer the question of interest: a Poisson regression model and marginal structural modeling (MSM). The simpler Poisson model is an extension of tabular rate of event analysis. The more complicated MSM model incorporates modeling of the treatment decision to more flexibly control for confounding by indication. For each outcome, the investigators will only record the first date an outcome occurs. Each outcome will be modeled separately.

Conditions: Hepatitis C, Chronic
Being tested: Direct Acting Antivirals
Keywords: Drug-Related Side Effects and Adverse Reactions, Antiviral Agents / Adverse Effects, Antiviral Agents / Toxicity, Simeprevir, Sofosbuvir, Ledipasvir, Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, Daclatasvir, Elbasvir, Grazoprevir, Velpatasvir, Ribavirin
Medical subject headings: Hepatitis C, Chronic, Drug-Related Side Effects and Adverse Reactions

What participants receive

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

Direct Acting AntiviralsDrug
The time period during which a patient is dispensed the medication and for up to 180 days after initiation of the medication.

Study groups in NCT03423641
Study group	Role	What they receive
Direct Acting Antivirals		Patients who receive a direct acting antiviral enter the DAA cohort at the time of initiation of the drug. Receives: Drug: Direct Acting Antivirals
Comparison		The exposure time of patients who have not received a direct acting antiviral (patients can change from the comparison to the DAA group once they receive the medication)

What is being measured

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

Incidence of Acute Myocardial Infarction (AMI)
Inpatient encounter with an ICD-9 diagnosis code of 410.xx or ICD-10 diagnosis code of I21.xx.
Measured: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Acute on Chronic Liver Failure
An acute change in MELD (model for end stage liver disease) score of 5 or more and the change is deemed to have persisted (defined as meeting one of the following criteria: MELD continues to be elevated 3 months later, liver transplant, death). The minimum value for the MELD is 6.43, but there is no maximum value. Higher scores mean a worse outcome.
Measured: Labs and diagnoses collected from clinical encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Acute Kidney Failure (AKF)
Encounters with an ICD-9 diagnosis code of 584.xx or ICD-10 diagnosis code of N17.xx.
Measured: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Multiple Organ Dysfunction Syndrome (MODS)
Inpatient encounters with ICD-9 diagnosis code of 995.92, 995.94, 785.52 or ICD-10 code of R65.11 or R65.2x.
Measured: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Death
Date of death in one or more records. Death data comes from medical records, Social Security, or state databases.
Measured: Death dates will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Ischemic Stroke
Inpatient encounters with ICD-9 diagnosis code of 433.xx, 434.xx or ICD-10 code of I63.xx, I65.xx.
Measured: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Hemorrhagic Stroke
Inpatient encounters with ICD-9 diagnosis code of 430.xx-432.xx or ICD-10 code of I60.xx-I62.xx
Measured: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Decompensated Cirrhosis
A patient will be characterized as having decompensated cirrhosis from an encounter indicating jaundice (ICD-9 diagnosis code of 782.4 or ICD-10 code of R17), ascites (ICD-9 diagnosis code of 789.5, 789.51, 789.59 or ICD-10 diagnosis code of R18.0, R18.8, K71.51, K70.11, or K70.31), or varices (ICD-9 diagnosis code of 456.0, 456.20 or ICD-10 diagnosis code of I85.01 or I85.11, or a medication dispense of lactulose or rifaximin along with a diagnosis of cirrhosis.
Measured: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Rate of Hospitalizations
An encounter in which the place of service is an inpatient hospitalization.
Measured: Hospitalizations will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Rate of Emergency Department Visits
An encounter in which the place of service is an emergency department or urgent care center.
Measured: ED visits will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Arrhythmia
Inpatient encounters with an ICD-9 diagnosis code of 427.1, 427.42, 427.5, 427.9 or an ICD-10 diagnosis code of I47.2, I49.01, I49.02, I46.9, I49.9.
Measured: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Liver Cancer
Encounters with ICD-9 diagnosis code of 155.xx or ICD-10 code of C22.xx.
Measured: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Cancers Other Than Liver Cancer
Encounters with ICD-9 codes 140.xx through 208.xx, except 155.xx or ICD-10 coes C00-C97 except C22.xx.
Measured: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of HBV Reactivation
We identified HBV reactivations in three different ways [Di Bisceglie et al., 2015; Yanny et al., 2018]: (1) patients who had a history of Hepatitis B core antibody (HBcAb) positive and were Hepatitis B surface antigen (HBsAg) negative at the time of initiating DAA therapy who became HBsAg positive within 180 days after receiving a DAA; (2) patients with undetectable levels of HBV DNA at the time of initiating DAA therapy who had a numerical result within 180 days after receiving a DAA; (3) patients with a numerical HBV DNA result at the time of initiating DAA therapy whose viral load increased by a factor of 10 within 180 days after receiving a DAA. For all methods of detecting a reactivation, we required that the reactivations be clinically significant: bilirubin at least 3, aspartate aminotransferase (AST) at least 400, or alanine aminotransferase (ALT) at least 500.
Measured: Labs will be for up to 180 days following the initiation of a DAA.

Timeline

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

1 Jan 201131 Dec 2017

First posted6 Feb 2018
Study start1 Jan 2011
Primary completion31 Dec 2017
Study completion31 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 33,808 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03423641
Sponsor's protocol ID: RI-RCR-1000
Status last verified: Aug 2019
First submitted: 31 Jan 2018
Last updated: 7 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
Individual data sharing: Undecided: Current plan is to make a de-identified data set available to investigators under specified conditions.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety of Direct-Acting Antiviral Medications for Hepatitis C
ClinicalTrials.gov ID: NCT03423641
Acronym / sponsor ID: RI-RCR-1000
Conditions: Hepatitis C, Chronic
Keywords: Drug-Related Side Effects and Adverse Reactions, Antiviral Agents / Adverse Effects, Antiviral Agents / Toxicity, Simeprevir, Sofosbuvir, Ledipasvir, Ombitasvir, Paritaprevir
Study type: Observational
Recruitment status: Completed
Enrolment: 33,808 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: OneFlorida Clinical Research Consortium, Patient-Centered Outcomes Research Institute
Study start: 1 Jan 2011 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 6 Feb 2018 (actual)
Results: Posted 7 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Direct Acting Antivirals	–	Drug: Direct Acting AntiviralsPatients who receive a direct acting antiviral enter the DAA cohort at the time of initiation of the drug.
Comparison	–	–The exposure time of patients who have not received a direct acting antiviral (patients can change from the comparison to the DAA group once they receive the medication)

Who may qualify

Ages: 18 to 88 years
Sex: All
Age groups: Adult, Older adult
Study population: The groups/cohorts will consist of all HCV patients from Kaiser Permanente Southern California region, Kaiser Permanente Northern California region, and the OneFlorida Clinical Research Consortium.

Key inclusion criteria (6 listed)

HCV viral load
HCV genotype
HCV qualitative
HCV antibody
HCV drug

Key exclusion criteria (7 listed)

Each outcome will be analyzed separately as time to first event, thus people who experience an outcome prior to their study start date are ineligible for analyses related to that particular outcome.
The results will be examined for sensitivity to the following possible exclusion criteria:
Achieved SVR-12 prior to index date
HCV treatment experienced prior to index date
No visit in GI, Infectious Disease, or Liver Transplant / Hepatology

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
Direct Acting AntiviralsThe time period during which a patient is dispensed the medication and for up to 180 days after initiation of the medication.	Drug	Direct Acting Antivirals

Primary outcome

Incidence of Acute Myocardial Infarction (AMI)
Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounter with an ICD-9 diagnosis code of 410.xx or ICD-10 diagnosis code of I21.xx.
Incidence of Acute on Chronic Liver Failure
Time frame: Labs and diagnoses collected from clinical encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
An acute change in MELD (model for end stage liver disease) score of 5 or more and the change is deemed to have persisted (defined as meeting one of the following criteria: MELD continues to be elevated 3 months later, liver transplant, death). The minimum value for the MELD is 6.43, but there is no maximum value. Higher scores mean a worse outcome.
Incidence of Acute Kidney Failure (AKF)
Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Encounters with an ICD-9 diagnosis code of 584.xx or ICD-10 diagnosis code of N17.xx.
Incidence of Multiple Organ Dysfunction Syndrome (MODS)
Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounters with ICD-9 diagnosis code of 995.92, 995.94, 785.52 or ICD-10 code of R65.11 or R65.2x.
Death
Time frame: Death dates will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Date of death in one or more records. Death data comes from medical records, Social Security, or state databases.
Incidence of Ischemic Stroke
Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounters with ICD-9 diagnosis code of 433.xx, 434.xx or ICD-10 code of I63.xx, I65.xx.
Incidence of Hemorrhagic Stroke
Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounters with ICD-9 diagnosis code of 430.xx-432.xx or ICD-10 code of I60.xx-I62.xx
Incidence of Decompensated Cirrhosis
Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
A patient will be characterized as having decompensated cirrhosis from an encounter indicating jaundice (ICD-9 diagnosis code of 782.4 or ICD-10 code of R17), ascites (ICD-9 diagnosis code of 789.5, 789.51, 789.59 or ICD-10 diagnosis code of R18.0, R18.8, K71.51, K70.11, or K70.31), or varices (ICD-9 diagnosis code of 456.0, 456.20 or ICD-10 diagnosis code of I85.01 or I85.11, or a medication dispense of lactulose or rifaximin along with a diagnosis of cirrhosis.
Rate of Hospitalizations
Time frame: Hospitalizations will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
An encounter in which the place of service is an inpatient hospitalization.
Rate of Emergency Department Visits
Time frame: ED visits will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
An encounter in which the place of service is an emergency department or urgent care center.
Incidence of Arrhythmia
Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounters with an ICD-9 diagnosis code of 427.1, 427.42, 427.5, 427.9 or an ICD-10 diagnosis code of I47.2, I49.01, I49.02, I46.9, I49.9.
Incidence of Liver Cancer
Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Encounters with ICD-9 diagnosis code of 155.xx or ICD-10 code of C22.xx.
Incidence of Cancers Other Than Liver Cancer
Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Encounters with ICD-9 codes 140.xx through 208.xx, except 155.xx or ICD-10 coes C00-C97 except C22.xx.
Incidence of HBV Reactivation
Time frame: Labs will be for up to 180 days following the initiation of a DAA.
We identified HBV reactivations in three different ways [Di Bisceglie et al., 2015; Yanny et al., 2018]: (1) patients who had a history of Hepatitis B core antibody (HBcAb) positive and were Hepatitis B surface antigen (HBsAg) negative at the time of initiating DAA therapy who became HBsAg positive within 180 days after receiving a DAA; (2) patients with undetectable levels of HBV DNA at the time of initiating DAA therapy who had a numerical result within 180 days after receiving a DAA; (3) patients with a numerical HBV DNA result at the time of initiating DAA therapy whose viral load increased by a factor of 10 within 180 days after receiving a DAA. For all methods of detecting a reactivation, we required that the reactivations be clinically significant: bilirubin at least 3, aspartate aminotransferase (AST) at least 400, or alanine aminotransferase (ALT) at least 500.

Results and safety

Results posted to the registry on 7 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Direct Acting Antivirals	15,524	15,193
Comparison	18,284	10,210

Primary outcome: Incidence of Acute Myocardial Infarction (AMI)

Time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.. Number (95% Confidence Interval). Unit: Events per 1000 person years

Measure	Direct Acting Antivirals n = 14959	Comparison n = 17421
Value	3.3 (2.0 to 4.7)	5.2 (4.6 to 5.8)

Direct Acting Antivirals vs Comparison: Odds Ratio (OR): .81 (95% CI 0.30 to 2.20), p = .68, Marginal Structural Model

Population analysed: The analysis population consists of the subset of patients without a prior diagnosis of MI.

Primary outcome: Incidence of Acute on Chronic Liver Failure

Time frame: Labs and diagnoses collected from clinical encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.. Number (95% Confidence Interval). Unit: Events per 1000 person years

Measure	Direct Acting Antivirals n = 13321	Comparison n = 13716
Value	16.5 (13.3 to 19.7)	24.1 (22.8 to 25.5)

Direct Acting Antivirals vs Comparison: Odds Ratio (OR): 0.71 (95% CI 0.56 to 0.91), p = 0.01, Marginal Structural Model

Population analysed: The analysis population consists of the subset of patients with MELD scores less than 15 at baseline.

Primary outcome: Incidence of Acute Kidney Failure (AKF)

Measure	Direct Acting Antivirals n = 14321	Comparison n = 16926
Value	24.2 (20.5 to 28.0)	33.7 (32.2 to 35.2)

Direct Acting Antivirals vs Comparison: Odds Ratio (OR): 0.92 (95% CI 0.75 to 1.12), p = 0.39, Marginal Structural Model

Population analysed: The analysis population consists of the subset of patients without a prior diagnosis of AKF.

Primary outcome: Incidence of Multiple Organ Dysfunction Syndrome (MODS)

Measure	Direct Acting Antivirals n = 15107	Comparison n = 17763
Value	9.7 (7.4 to 12.0)	17.2 (16.2 to 18.3)

Direct Acting Antivirals vs Comparison: Odds Ratio (OR): 0.67 (95% CI 0.49 to 0.90), p = 0.01, Marginal Structural Model

Population analysed: The analysis population consists of the subset of patients without a prior diagnosis of MODS.

Adverse events

Time frame: This was a retrospective observational study, so any adverse event data would have been collected during contact with a medical provider.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Direct Acting Antivirals	0 of 15,524 (0%)	0 of 15,524 (0%)	77 of 15,524
Comparison	0 of 18,284 (0%)	0 of 18,284 (0%)	2,186 of 18,284

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. Current plan is to make a de-identified data set available to investigators under specified conditions.

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
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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.

Elizabeth A McGlynn, PhD principal investigator

Kaiser Permanente

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Kaiser Permanente.

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 6 inclusion and 7 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Acute Myocardial Infarction (AMI) (time frame: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.). The study lists 14 primary outcomes in all. 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 NCT03423641.

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 7 Aug 2019.