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Antibiotic

Doxycycline for Heart Attack

Phase 2
Recruiting
Led By Neil Brass, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary STEMI
18+ year old
Must not have
Cardiogenic shock
Low risk inferior STEMI (total ST elevation plus depression <4mm)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post intervention
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions

Summary

This trial is testing whether doxycycline, a drug commonly used to treat skin conditions and gum disease, can also help prevent heart disease in people who have recently had a heart attack.

Who is the study for?
This trial is for adults over 18 who've had a recent severe heart attack (STEMI) and are admitted to the Royal Alexandra Hospital in Edmonton. It's not for those with low-risk conditions, previous heart attacks or failure, allergies to tetracyclines, life expectancy less than a year due to other diseases, poor kidney function, or factors that prevent MRI use.
What is being tested?
The study tests if doxycycline can protect the heart after an attack. Participants will take either doxycycline or a placebo twice daily for seven days post-heart attack. Their heart health will be assessed via MRI three months later to see if doxycycline improves their condition.
What are the potential side effects?
While past studies showed no adverse effects from using doxycycline in similar settings, potential side effects may include digestive issues like nausea and diarrhea, allergic reactions, sun sensitivity, and rarely teeth discoloration or liver impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a major heart attack.
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I am 18 years old or older.
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I have been diagnosed with a severe type of heart attack.
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My symptoms started less than 12 hours ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have experienced a severe heart condition known as cardiogenic shock.
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My heart attack was classified as low risk.
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I have poor kidney function or cannot undergo an MRI due to other health reasons.
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My treatment started more than 24 hours after my symptoms began.
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I am currently using medication to break up blood clots.
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I have had a heart attack or heart failure in the past.
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I do not have any health conditions that would shorten my life to under a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Left ventricular end-systolic volume index (LVESVi)
Secondary study objectives
Composite endpoint of mortality and hospital admission due to re-infarction, heart failure, or stroke
Infarct size
Left ventricular ejection fraction (LVEF)
+1 more

Side effects data

From 2015 Phase 2 & 3 trial • 149 Patients • NCT01968460
20%
NAUSEA
16%
SOMNOLENCE
10%
DIZZINESS
8%
fatigue
8%
tremor
6%
insomnia
4%
orthostatic hypotension
4%
nasopharyngitis
2%
ACUTE MYOCARDIAL INFARCTION
2%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
P2B001 Treatment A
P2B001 Treatment B
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Doxycycline hyclateExperimental Treatment1 Intervention
Two 100mg doxycycline capsules (200 mg) p.o. upon enrollment, followed by one 100 mg capsule p.o. every 12 hours for 7 days
Group II: Placebo controlPlacebo Group1 Intervention
Two placebo capsules upon enrollment, followed by one placebo capsule p.o. every 12 hours for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
FDA approved

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,239 Total Patients Enrolled
28 Trials studying Heart Failure
5,955 Patients Enrolled for Heart Failure
Royal Alexandra HospitalOTHER
17 Previous Clinical Trials
8,071 Total Patients Enrolled
Neil Brass, MDPrincipal InvestigatorDept. of Medicine, University of Alberta
Kevin Bainey, MDPrincipal InvestigatorDept. of Medicine, University of Alberta
Raymond Leung, MDPrincipal InvestigatorCK Hui Heart Centre, Royal Alexandra Hospital, Edmonton, Alberta.
Richard Schulz, PhDStudy ChairDept. of Pediatrics and Pharmacology, University of Alberta
1 Previous Clinical Trials
380 Total Patients Enrolled
Peter Hwang, MD, PhDStudy DirectorDept. of Medicine, University of Alberta
Benjamin Tyrrell, MDStudy DirectorDept. of Medicine, University of Alberta
Richard Coulden, MDPrincipal InvestigatorDept. of Radiology and Diagnostic Imaging, University of Alberta
Richard Thompson, MDPrincipal InvestigatorDept. of Biomedical Engineering, University of Alberta

Media Library

Doxycycline Hyclate (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03508232 — Phase 2
Heart Failure Research Study Groups: Doxycycline hyclate, Placebo control
Heart Failure Clinical Trial 2023: Doxycycline Hyclate Highlights & Side Effects. Trial Name: NCT03508232 — Phase 2
Doxycycline Hyclate (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03508232 — Phase 2
~0 spots leftby Dec 2024
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