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Anti-inflammatory Agent

DFV890 for Coronary Heart Disease

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female participants aged between 18 - 80 years (inclusive) at the start of screening will be included.

Participants must have hsCRP levels ≥ 2 mg/L at two timepoints during screening. Screening values must be separated by a minimum of 8 days. The initial hsCRP value must be a minimum of 30 days after the qualifying MI or after any percutaneous coronary intervention (PCI) performed separately from the qualifying MI.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 22 to end of study visit (up to 92 days)

Awards & highlights

Study Summary

This trial will test a daily pill to reduce inflammation markers linked to heart disease in 24 people with existing heart issues.

Who is the study for?

Adults aged 18-80 with coronary heart disease who are on a stable statin regimen and have high levels of inflammation markers (hsCRP ≥ 2 mg/L). They must not have plans for heart surgery during the study, no recent major infections or immune-targeting biologic drug use, and should not be taking certain other medications.Check my eligibility

What is being tested?

The trial is testing DFV890, an oral medication given daily for 12 weeks to see if it can lower inflammation related to cardiovascular risk in people with heart disease. It's compared against a placebo to check its effectiveness and safety.See study design

What are the potential side effects?

While specific side effects of DFV890 aren't listed, common risks may include gastrointestinal issues, allergic reactions, potential liver impact due to drug interactions, and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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My hsCRP levels were 2 mg/L or higher at two different times after my heart attack.

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My BMI is between 18 and 40.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 22 to end of study visit (up to 92 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 22 to end of study visit (up to 92 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 22 to end of study visit (up to 92 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum levels of IL-6 and IL-18

Secondary outcome measures

Plasma trough concentrations (Ctrough) of DFV890 at steady state

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment sequence 3Experimental Treatment1 Intervention

Participants will be administered different doses of DFV890

Group II: Treatment sequence 2Experimental Treatment2 Interventions

Participants will be administered Placebo and different doses of DFV890

Group III: Treatment Sequence 1Experimental Treatment2 Interventions

Participants will be administered Placebo and different doses of DFV890

Group IV: Treatment sequence 4Placebo Group1 Intervention

Participants will be administered Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DFV890

2021

Completed Phase 2

~150

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,285 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to individuals aged eighty-five and above?

"This medical trial is recruiting patients aged between 18 and 80 years."

Answered by AI

Is Treatment sequence 2 a risk-free alternative for patients?

"Our analysis gave Treatment sequence 2 a score of two; this indicates that there is some evidence validating its safety, but none regarding efficacy as it is only in Phase 2."

Answered by AI

Is there currently a recruitment effort underway for this research endeavor?

"The details found on clinicaltrials.gov suggest that this research trial is actively recruiting participants. It was first posted online in October of 2023 and the most recent modification to the study occurred a few days later."

Answered by AI

What is the enrollment figure for this experiment?

"Affirmative. According to the clinicaltrials website, this medical trial opened up enrollment on October 18th 2023 and is still actively seeking participants. 24 individuals are required at a single location for participation."

Answered by AI

Might I be qualified to enroll in this experiment?

"This study requires 24 participants aged 18-80 with coronary heart disease. Qualifying individuals must be male or female, have a body mass index between 18 and 40 kg/m2, had an MI at least 30 days before screening, hsCRP levels of ≥ 2 mg/L on two separate occasions (separated by 8 days), and for those taking statins, they need to have been stable on the same dose for 4 weeks prior to randomization."

Answered by AI