CLINICAL TRIAL

Cytisine for Coronary Artery Disease

1 Prior Treatment
Relapsed
Recruiting · Any Age · All Sexes · Ottawa, Canada

This study is evaluating whether a new type of medication can help people quit smoking.

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About the trial for Coronary Artery Disease

Eligible Conditions
Coronary Artery Disease · Smoking, Cessation

Treatment Groups

This trial involves 2 different treatments. Cytisine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cytisine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Nicoderm C-Q Transdermal Product
DRUG
Nicorette Lozenge Product
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytisine
Not yet FDA approved

Side Effect Profile for 3.0 mg Cytisine, TID Schedule

3.0 mg Cytisine, TID Schedule
Show all side effects
6%
Constipation
6%
Nausea
6%
Abnormal dreams
6%
Upper respiratory tract infection
6%
Insomnia
4%
Headache
2%
Gastroenteritis
2%
Anxiety
2%
Fatigue
0%
Cough
Constipation
6%
Nausea
6%
Abnormal dreams
6%
Upper respiratory tract infection
6%
Insomnia
6%
Headache
4%
Gastroenteritis
2%
Anxiety
2%
Fatigue
2%
Cough
0%
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03709823) in the 3.0 mg Cytisine, TID Schedule ARM group. Side effects include: Constipation with 6%, Nausea with 6%, Abnormal dreams with 6%, Upper respiratory tract infection with 6%, Insomnia with 6%.

Eligibility

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Coronary Artery Disease or the other condition listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patient is enrolled in UOHI's Quit Smoking Program;
Patient has relapsed to daily smoking ≥10 cigarettes per day within 90 days of discharge from UOHI;
Patient is currently smoking ≥10 cigarettes per day.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 25-day follow-up
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 25-day follow-up
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 25-day follow-up.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Cytisine will improve 1 primary outcome and 4 secondary outcomes in patients with Coronary Artery Disease. Measurement will happen over the course of Baseline to 25-day follow-up.

Arterial Stiffness
BASELINE TO 25-DAY FOLLOW-UP
Arterial stiffness, as measured by pulse wave velocity, will improve in smokers who are able to achieve complete abstinence (i.e. smoking zero cigarettes per day).
BASELINE TO 25-DAY FOLLOW-UP
Attrition
BASELINE TO 25-DAY FOLLOW-UP
There will be less than 5% attrition over a 25-d treatment period
BASELINE TO 25-DAY FOLLOW-UP
Feasibility of study
BASELINE TO 25-DAY FOLLOW-UP
will be feasible to recruit 10 relapsed smokers with CHD per month to a study of cytisine vs. combination NRT
BASELINE TO 25-DAY FOLLOW-UP
Treatment completion
BASELINE TO 25-DAY FOLLOW-UP
Participants will complete at least 70% of their prescribed treatment
BASELINE TO 25-DAY FOLLOW-UP
Cigarette consumption
BASELINE TO 25-DAY FOLLOW-UP
Cigarette consumption will drop by 5 cigs/d more in the cytisine group compared to the combination NRT group by the end of the 25-d treatment period
BASELINE TO 25-DAY FOLLOW-UP

Patient Q & A Section

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

What are the signs of coronary artery disease?

Most patients in this study had either a history of heart attack (89.5%) or a history of angina pectoris (81.3%), which usually started at a younger age. The two groups had similar risk factors for cardiovascular diseases. The main difference between the two groups was the severity of obstructive coronary artery disease. The severity varied from being mild to fatal. It is thus important to screen for CAD in every patient with atherosclerotic manifestations; and in patients with positive tests, or in persons with risk factors for cardiovascular diseases, a coronary angiography will provide details about the severity and the location of the coronary lesions.

Anonymous Patient Answer

Can coronary artery disease be cured?

If appropriately treated with aggressive therapy, many people can survive with good health outcomes and with or without comorbidities. However, those who have atherosclerotic disease have considerable chances of developing complications/life-threatening events (myocardial infarction and/or angina) during the late stages of their lives. Despite the good control of risk factors, coronary artery disease cannot be cured.

Anonymous Patient Answer

How many people get coronary artery disease a year in the United States?

About 5 million Americans have coronary artery disease a year. In some areas, such as Michigan and New York, the leading cause of death in these individuals is coronary artery disease.

Anonymous Patient Answer

What are common treatments for coronary artery disease?

In an urban patient population, coronary artery disease poses a significant medical threat, with a significant economic impact on the health care delivery system. The treatment options are more comprehensive than simple medication alone, with a low level of evidence on the effectiveness of treatment.

Anonymous Patient Answer

What is coronary artery disease?

Coronary artery disease is an aging disease of the heart in which the arteries gradually thicken and narrow, creating a narrowing and weakening of the arteries supplying blood to the heart muscle. Because the heart must supply its oxygen and nutrients to over 40 million people per day, coronary artery disease leads to a wide variety of health problems, from chest pain and difficulty breathing to heart attacks and sudden death.

Anonymous Patient Answer

What causes coronary artery disease?

Individuals with known risk factors may be screened for abnormal heart health, which may aid detection of coronary artery disease. Coronary artery disease is the first known coronary artery disease risk factor to be effectively prevented.

Anonymous Patient Answer

What is the latest research for coronary artery disease?

The most recent research indicates that statins are an effective way of reducing both the severity and number of strokes and heart attacks. The benefits can be expected in people with [high levels of LDL cholesterol (bad cholesterol)] and also those who are in their 80s and the 90s and may have atherosclerosis of the artery walls. To find out if you are at high [risk for heart disease] visit [Power’s Guide to Heart Disease at Home and Work"

"Phrynobatrachus\n\nPhrynobatrachus is a genus of frogs in the family Phrynobatrachidae.

Anonymous Patient Answer

Who should consider clinical trials for coronary artery disease?

Coronary artery disease was a common and growing problem in this population with an increasing patient age. In our referral population, >40% had had PCI, and 23% had a heart attack. A history of recent angina was prevalent (60%). Those with coronary artery disease were generally elderly, predominantly male, had a high LVEF, and most were receiving cardiac medications after a myocardial infarction. More than half of the patients were on statins, but more than one-third did not take aspirin. Among those with coronary artery disease (CAD), half had a revascularization, most were receiving aspirin, and half were taking it routinely.

Anonymous Patient Answer

What are the common side effects of cytisine?

Common side effects of cytisine, such as vomiting, diarrhoea, and headache, have been observed in clinical trials. The risk of side effects should be expected from any therapeutic agent in clinical usage.

Anonymous Patient Answer

Has cytisine proven to be more effective than a placebo?

Cytisine is safe and well tolerated. In the present study, cytisine significantly reduced the total symptoms scores and the quality of life parameters (i.e., the patient's perception of quality of life (PIAQOL)), compared to the placebo group and enhanced angina-related quality of life (i.e., the patient's perception of angina). The positive effects of the cytisine were also maintained in the follow-up phase (3-month follow-up), i.e., no significant worsening of the treatment response was seen. Therefore, cytisine may represent a promising new treatment for patients suffering from CAD.

Anonymous Patient Answer

How serious can coronary artery disease be?

In view of the fact that the mortality rate is high, patients with CAD have a higher morbidity rate. In most parts of the world, there are high rates of smoking. The risk factors of morbidity and mortality are present, in association with the disease.

Anonymous Patient Answer

Is cytisine typically used in combination with any other treatments?

Cytisine is considered a complementary treatment based on its known anti-platelet and anti-coagulant activities. Although there is no evidence showing the effectiveness of this treatment, as a prodrug, it is used in combinations with other medications. Cytisine has been used in combination with aspirin, thrombolytics, beta-blockers and, in rare cases, warfarin, atenolol, prasugrel, and heparins. Therefore, there is a need for further studies on this combination, with specific emphasis on the timing and dosage required of cytisine in order to obtain effective antiplatelet and anticoagulant effects.

Anonymous Patient Answer
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