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Antibiotic
Doxycycline for Heart Attack
Phase 2
Recruiting
Led By Richard Coulden, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post intervention
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Left ventricular end-systolic volume index (LVESVi)
Secondary outcome measures
Composite endpoint of mortality and hospital admission due to re-infarction, heart failure, or stroke
Infarct size
Left ventricular ejection fraction (LVEF)
+1 moreSide effects data
From 2015 Phase 2 & 3 trial • 149 Patients • NCT0196846020%
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
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
889 Previous Clinical Trials
384,964 Total Patients Enrolled
25 Trials studying Heart Failure
5,463 Patients Enrolled for Heart Failure
Royal Alexandra HospitalOTHER
17 Previous Clinical Trials
7,758 Total Patients Enrolled
Richard Schulz, PhDStudy ChairDept. of Pediatrics and Pharmacology, University of Alberta
1 Previous Clinical Trials
380 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have experienced a severe heart condition known as cardiogenic shock.My heart attack was classified as low risk.I have poor kidney function or cannot undergo an MRI due to other health reasons.I had a major heart attack.My treatment started more than 24 hours after my symptoms began.I am currently using medication to break up blood clots.You are allergic to tetracycline antibiotics.I am 18 years old or older.I have had a heart attack or heart failure in the past.I do not have any health conditions that would shorten my life to under a year.I have been diagnosed with a severe type of heart attack.My symptoms started less than 12 hours ago.
Research Study Groups:
This trial has the following groups:- Group 1: Doxycycline hyclate
- Group 2: Placebo control
Awards:
This trial has 2 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is Doxycycline hyclate typically used?
"Doxycycline hyclate is most often prescribed to acne patients. However, it has also been found effective in treating conditions like trachoma and klebsiella infections."
Answered by AI
Are patients currently able to sign up for this research opportunity?
"From what is detailed on clinicaltrials.gov, this trial is still actively searching for patients. The date when this search began was January 6th 2020, with the most recent update being October 13th 2022."
Answered by AI
What possible side effects could Doxycycline hyclate have on test subjects?
"Doxycycline hyclate is a medication that, according to our evaluation, falls into level 2 of safety. This means that while there is evidence suggesting it is safe, none of the trials done thus far support its efficacy."
Answered by AI
How many people have been chosen to participate in this clinical trial?
"That is accurate. According to the listing on clinicaltrials.gov, this trial was first announced on January 6th 2020 and is still recruiting patients. A total of 170 individuals are needed for the study, which is only being conducted at a single location."
Answered by AI
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