Zontivity

prophylaxis of cardiovascular event, Peripheral Arterial Disease, Heart Attack + 1 more

Treatment

5 FDA approvals

20 Active Studies for Zontivity

What is Zontivity

Vorapaxar

The Generic name of this drug

Treatment Summary

Vorapaxar is a drug used to reduce the risk of blood clots in people with a history of heart attack or peripheral arterial disease. It works by blocking a protein called protease activated receptor (PAR-1), which is found on platelets, and prevents them from sticking together and forming clots.

Zontivity

is the brand name

image of different drug pills on a surface

Zontivity Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Zontivity

Vorapaxar

2014

3

Approved as Treatment by the FDA

Vorapaxar, otherwise called Zontivity, is approved by the FDA for 5 uses which include Peripheral Arterial Disease (PAD) and Heart Attack .

Peripheral Arterial Disease (PAD)

Heart Attack

prophylaxis of cardiovascular event

Cardiovascular Events

Peripheral Arterial Disease

Effectiveness

How Zontivity works in the body

Vorapaxar prevents blood clots by blocking a protein that responds to thrombin, a substance in the blood that helps create blood clots. Vorapaxar does this by stopping the protein from responding to thrombin and blocking platelet aggregation. It does not affect platelets when they are exposed to other substances like collagen or adenosine diphosphate.

When to interrupt dosage

The suggested dosage of Zontivity is contingent upon the specified condition, including Peripheral Arterial Disease, Cardiovascular Events and prophylaxis of cardiovascular event. The amount of dosage depends upon the method of delivery, as outlined in the table below.

Condition

Dosage

Administration

prophylaxis of cardiovascular event

2.08 mg, , 2.5 mg

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral

Peripheral Arterial Disease

2.08 mg, , 2.5 mg

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral

Heart Attack

2.08 mg, , 2.5 mg

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral

Cardiovascular Events

2.08 mg, , 2.5 mg

Tablet, film coated, , Oral, Tablet, film coated - Oral, Tablet, Tablet - Oral

Warnings

Zontivity has four contraindications, and it should not be consumed in combination with the conditions described in the table below.

Zontivity Contraindications

Condition

Risk Level

Notes

Hemorrhage

Do Not Combine

Stroke

Do Not Combine

Transient Ischemic Attack (TIA)

Do Not Combine

Brain Hemorrhage

Do Not Combine

There are 20 known major drug interactions with Zontivity.

Common Zontivity Drug Interactions

Drug Name

Risk Level

Description

(R)-warfarin

Major

The risk or severity of bleeding and hemorrhage can be increased when Vorapaxar is combined with (R)-warfarin.

(S)-Warfarin

Major

The risk or severity of bleeding and hemorrhage can be increased when Vorapaxar is combined with (S)-Warfarin.

4-hydroxycoumarin

Major

The risk or severity of bleeding and hemorrhage can be increased when Vorapaxar is combined with 4-hydroxycoumarin.

Abciximab

Major

The risk or severity of bleeding and hemorrhage can be increased when Vorapaxar is combined with Abciximab.

Abemaciclib

Major

The serum concentration of Abemaciclib can be increased when it is combined with Vorapaxar.

Zontivity Toxicity & Overdose Risk

Vorapaxar may increase the risk of bleeding and brain bleeding, so it is not recommended for those who have had strokes, mini-strokes, brain bleeds, or active bleeding from a peptic ulcer. There are not enough studies to know if vorapaxar is safe for pregnant women or for breastfeeding mothers, but animal studies suggest that there is a low risk of fetal toxicity. It is also unknown if vorapaxar or its byproducts can be found in human milk.

image of a doctor in a lab doing drug, clinical research

Zontivity Novel Uses: Which Conditions Have a Clinical Trial Featuring Zontivity?

104 active clinical trials are currently in progress to investigate the potential of Zontivity to alleviate Peripheral Arterial Disease, Heart Attack and avert cardiovascular events.

Condition

Clinical Trials

Trial Phases

Peripheral Arterial Disease

36 Actively Recruiting

Not Applicable, Phase 3, Phase 1, Early Phase 1, Phase 2, Phase 4

Cardiovascular Events

4 Actively Recruiting

Not Applicable

Heart Attack

23 Actively Recruiting

Not Applicable, Phase 1, Phase 4, Phase 2, Early Phase 1, Phase 3

prophylaxis of cardiovascular event

0 Actively Recruiting

Zontivity Reviews: What are patients saying about Zontivity?

5

Patient Review

6/9/2015

Zontivity for Treatment to Prevent Peripheral Artery Thromboembolism

4.7

Patient Review

9/22/2017

Zontivity for Treatment to Prevent Peripheral Artery Thromboembolism

image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about zontivity

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

What is Zontivity used for?

"Vorapaxar prevents heart attacks and strokes by blocking platelets from forming blood clots."

Answered by AI

Is vorapaxar FDA approved?

"The FDA has approved ZONTIVITY for the reduction of thrombotic cardiovascular events in patients with a history of heart attack or peripheral arterial disease. driven by an 18 percent relative risk reduction in MI [5.4 percent vs. first stroke [1.2 percent vs."

Answered by AI

Is Zontivity a blood thinner?

"Zontivity is a medication designed to reduce the formation of blood clots. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke, the FDA stated."

Answered by AI

Who manufactures Zontivity?

"ZONTIVITY tablets, 2.08 mg vorapaxar, are oval-shaped, yellow, film-coated tablets with “351” on one side and the Merck logo on the other."

Answered by AI

Clinical Trials for Zontivity

Image of Brigham and Women's Hospital in Boston, United States.

Rosuvastatin for Cancer-Associated Blood Clots

18+
All Sexes
Boston, MA

Patients with cancer are at high risk for life-threatening venous thromboembolism (VTE) yet rarely receive anticoagulant prophylaxis due to bleeding risks. Thus, effective prophylaxis in oncology requires a method to reduce VTE without increasing hemorrhage. The primary aim of the Statin Therapy to Prevent Cancer Associated Venous Thromboembolism (STAT-CAT) trial is to test whether rosuvastatin 20 mg daily for 12 months compared to placebo can safely prevent VTE in patients with newly diagnosed or recently relapsed cancer who are at increased thrombotic risk, are not planned to be anticoagulated, and who do not otherwise take statin therapy.

Phase 4
Waitlist Available

Brigham and Women's Hospital (+1 Sites)

Image of University of Nebraska at Omaha Health Science Collaborative in Omaha, United States.

Pulse Arrival Time for Peripheral Artery Disease

18+
All Sexes
Omaha, NE

1\) The purpose of this study is to assess segmental pulse arrival time (PAT) as an alternative biomarker to detect lower-extremity peripheral artery disease (PAD). The secondary purpose will be to investigate the impacts of age on segmental PAT. The subject population will include any adults 19 years of age or older with or without PAD. Exclusion criteria include having an aortic aneurysm with or without previous intervention, previous revascularization surgeries of the arteries in the legs/aorta, walking impairments independent of PAD, gangrene or ulcers of the toes/feet, and currently pregnant or breastfeeding. 3) All aims of the present study will be completed with a single laboratory visit. Descriptive measurements will include height, weight, age, sex, body fat percentage, and self-reported medication and health history. Subjects will lie in the supine position for 20-min. After rest, either the ankle-brachial index (ABI) or PAT will be assessed. After 10-min of further rest, the other measurement will be performed. ABIs will be assessed according to current guidelines: blood pressures will be assessed in the dorsal pedis and tibialis posterior arteries of both legs and the brachial arteries of both arms using a blood pressure cuff and Doppler ultrasound. PAT will be simultaneously assessed in both arms and legs using an investigational device with a 3-lead electrocardiogram sensor and four photoplethysmography (PPG) sensors. A PPG sensor will be applied to both middle fingers and both big toes. Signals will be collected for 15-min. Thermal images of the fingers and toes will be assessed before and after using the investigational device. After assessment of ABI and PAT, subjects will participate in a 6-min walking test (6MWT) to objectively establish walking capacity. The 6MWT will be performed in accordance with current guidelines. Cones will be separated by 30 meters on a straight flat walkway. Subjects will be instructed to walk back and forth between the cones as fast as they can for 6-min. Subjects will be allowed to rest during the test, if necessary, but the stopwatch will continue to run. Segmental PATs will be compared with ABI and 6-min walking time to determine if segmental PATs can predict lower-extremity PAD (ABI) and the associated walking impairment (6MWT). This study is expected to last \~2hrs. 4) There will be no follow-up.

Waitlist Available
Has No Placebo

University of Nebraska at Omaha Health Science Collaborative

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Image of St Boniface Hospital in Winnipeg, Canada.

Remote Home Monitoring for Heart Attack

18+
All Sexes
Winnipeg, Canada

Heart attacks are one of the top causes of death in Canada, with over 2,100 cases treated each year in Manitoba. Even though hospital care has improved, the period after going home is still risky. Many patients feel anxious and unsure about their recovery, and without enough support, they often end up back in the emergency department (ED). This is an even bigger challenge for people in rural areas, where getting follow-up care can be much harder. Filling these gaps is important to help patients get better and to reduce stress on the healthcare system. In a previous study, the investigators found that extra support made a big difference: only 8% of participants using a digital health tool returned to the ED within 30 days, compared to 22% of participants without it. Now, the investigators want to expand this study across Manitoba to see if digital health tools can help more people recover safely at home. The investigators will compare two types of follow-up care: education only versus education with extra support (like symptom tracking and virtual appointments). The investigators will look at how this affects hospital visits, mental well-being, and healthcare costs. The goal is to create a better support system for people after a heart attack, leading to healthier recoveries, less strain on hospitals, and better care for Manitobans - no matter where they live.

Waitlist Available
Has No Placebo

St Boniface Hospital

Image of Baystate Medical Center in Springfield, United States.

Consent Approaches for Heart Disease Rehabilitation

18+
All Sexes
Springfield, MA

Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend. New strategies are needed to help more patients attend cardiac rehabilitation. In this study, the investigators will see if using an $50 incentive, case management, text messages, and physical activity coaching combined into a single intervention will help more patients attend cardiac rehabilitation. In preparation for a larger trial, patients will also be randomly assigned to four different ways of seeking their permission to be in a research study. The investigators will see if these approaches affect how many people participate in the research project. The two main goals of this study is to understand: 1. If the consent approach type impacts participation rates in the research study 2. If the multi-component intervention (case management, financial incentives, text messages, and physical activity coaching) improves cardiac rehabilitation participation within 3 months.

Waitlist Available
Has No Placebo

Baystate Medical Center

Quinn R Pack, MD, MSc

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Image of The Ohio State University Wexner Medical Center in Columbus, United States.

Health Coaching for Cardiovascular Disease

18+
All Sexes
Columbus, OH

For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.

Waitlist Available
Has No Placebo

The Ohio State University Wexner Medical Center

Beth Steinberg, PhD, RN

Image of University of Arizona in Tucson, United States.

Exercise and Beetroot Juice for Peripheral Arterial Disease

18+
All Sexes
Tucson, AZ

Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients. Investigators hypothesize that home-based exercise combined with lower extremity revascularization will significantly improve walking performance compared to revascularization alone in patients with PAD undergoing revascularization for disabling PAD. Investigators further hypothesize that inorganic nitrate, a major source of nitric oxide (NO) abundant in beetroot juice, will improve walking performance after lower extremity revascularization, compared to placebo. In preclinical models, NO inhibits inflammation, neointimal hyperplasia, thrombosis, and vascular smooth muscle cell migration at sites of revascularization. NO increases angiogenesis and perfusion, repairs skeletal muscle damaged by ischemia, and stimulates mitochondrial activity. In a randomized clinical trial with a 2 x 2 factorial design, the trial will test the following two primary hypotheses in 386 patients randomized within three months of a successful lower extremity revascularization for disabling PAD: First, that home-based exercise combined with lower extremity revascularization will improve six-minute walk distance more than revascularization alone at 6-month follow-up (Primary Aim #1). Second, that nitrate-rich beetroot juice combined with lower extremity revascularization will improve six-minute walk, compared to placebo combined with revascularization at 6-month follow-up (Primary Aim #2).

Phase 3
Recruiting

University of Arizona (+7 Sites)

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