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Drug Trials Snapshots: KENGREAL

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the KENGREAL Prescribing Information for complete information.

KENGREAL (cangrelor)
(KEN-greal)
The Medicines Company
Approval date: June 22, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

KENGREAL is a drug known as a “blood thinner” that prevents the formation of blood clots in the blood vessels of the heart (coronary arteries) in patients undergoing a procedure called percutaneous coronary intervention (PCI). This procedure, also known as coronary angioplasty, is used to open a blocked or narrowed heart artery to improve blood flow to the heart muscle.

During PCI, the arteries are opened by inflating a balloon at the site of the narrowing, usually followed by placement of a small tube called a stent to keep the artery open.

How is this drug used?

KENGREAL is given by a health care professional directly into the bloodstream through a needle in the vein. This is known as an intravenous, or IV, infusion.

What are the benefits of this drug?

KENGREAL reduces the risk of serious blood clotting complications related to PCI, including heart attack, blockage of the stent, and a need for further procedures to reopen an artery.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

Subgroup analyses were conducted for sex, race, and age.

  • Sex: KENGREAL was similarly effective in men and women.
  • Race: The majority of patients in the trial were white. Differences in response to KENGREAL among races could not be determined.
  • Age: KENGREAL was similarly effective in all age groups studied.

What are the possible side effects?

The most common side effect of KENGREAL during clinical trials was bleeding, which can be serious. This is because KENGREAL is a medicine that interferes with the process of blood clotting in the body, making bleeding more likely.

Were there any differences in side effects among sex, race and age?

Subgroup analyses were conducted for sex, race, and age.

  • Sex: More bleeding was seen in women taking KANGREAL compared to men taking KANGREAL. In the trial, all patients (men and women) treated with KANGREAL had more bleeding compared to patients given another blood thinner called clopidogrel.
  • Race: The majority of patients in the trial were white. Differences in bleeding among races could not be determined.
  • Age: More bleeding was observed in patients 65 and older treated with KANGREAL compared to younger patients taking KANGREAL. In the trial, all patients (in every age group) treated with KANGREAL had more bleeding compared to patients given another blood thinner called clopidogrel.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved KENGREAL based on evidence from a clinical trial that enrolled 11,145 patients with blockages in the arteries of the heart (known as coronary artery disease) and who were to undergo PCI. The trial was conducted in the United States, Canada, South America, Asia, and New Zealand. The same trial was used to assess the benefit and the side effects of the drug.

The figure below summarizes how many men and women were enrolled in the clinical trial.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing the percentage of patients by sex enrolled in the clinical trial of the drug KENGREAL. Out of 11,145 patients who participated in the clinical trial 72% were men and 28% were women.

Source: Company Clinical Trial Data

The figure and table below summarize how many patients by race were enrolled in the clinical trial.

Figure 2. Baseline Demographics by Race

Figure 2. Baseline Demographics by Race KENGREAL

*Other=Native Hawaiian or Pacific Islander, American Indian or Alaskan Native and Unknown combined
Source: Company Clinical Trial Data

Table 1b. Baseline Demographics by Race

Race Number of Patients Percentage
White 10437 94
Black or African American 308 3
Asian 350 3
Other* 50 <>

*Other=Native Hawaiian or Pacific Islander, American Indian or Alaskan Native and Unknown combined
Source: Company Clinical Trial Data

The figure below summarizes how many patients by age were enrolled in the clinical trial.

Figure 3. Baseline Demographics by Age

Pie chart summarizing the percentage of patients by age enrolled in the KENGREAL clinical trial: 82% of patients were younger than 75 years and 18% were 75 years and older.

Source: Company Clinical Trial Data

How was the trial designed?

There was one trial that evaluated the benefit and side effects of KENGREAL. Patients were randomly assigned to receive either KENGREAL for 2 hours or until the PCI was completed, or an approved drug called clopidogrel given around the time of PCI. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. When the KANGREAL infusion was stopped after 2 hours or completion of the PCI, clopidogrel was given.

The trial was designed to compare the numbers of patients in the two groups who had one or more of the following events: death, heart attack, clogged stents, and repeated heart procedure that occurred in the first 48 hours after PCI.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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