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For Patients

Who can take part?

Have you or a family member just had a heart attack (also known as a myocardial infarction)?

If so, you or they may be able to take part in a new clinical study called dal-GenE-2 (also known as dal-302).

  • Anyone who is aged 45 years or older
  • Lives in North America (United States or Canada)
  • Has been in hospital for an acute coronary syndrome (ACS) - e.g., a heart attack - within the past 3 months
  • Is medically stable on current treatment for this recent ACS

What you can expect from participating in the study

  • A study duration of approximately 48 months
  • A test to determine if you have the right genotype to participate in the study
  • Initial on-site visits followed by remote visits to make study participation simple
  • Study medication should be taken once a day with the largest meal of the day (usually dinner).
  • You will continue to take all your current medication while on the study
  • You will be randomly chosen to either receive the study drug or a placebo which looks like the study drug but has no medicine in it
  • All care, tests and medication that are part of the study will be provided to you at no cost.

About Clinical Trials

What are clinical trials?

Clinical trials also known as clinical research is medical research that studies people to understand health and disease. Clinical research helps improve the way doctors treat and prevent illness. Through clinical research, researchers learn:
  • How the body works
  • How illness develops in people, such as how diseases get better or worse over time
  • How the body handles a possible treatment
  • Which behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illness
  • The goal is to use science to improve people’s health care and health over time. The participants who join and take part in clinical research studies may or may not get any benefit for themselves.

Cardiovascular Disease and Acute Coronary Syndrome (ACS)

Cardiovascular disease (CVD) is the leading cause of death among adults worldwide with approximately 17.9 million people losing their life to CVD every year. CVD is a group of disorders of the heart and blood vessels and include coronary heart disease (CHD). More than four out of five CVD deaths are due to heart attacks and strokes, and one third of these deaths occur prematurely in people under 70 years of age.

Acute Coronary Syndrome, which somebody must have recently had to be eligible for this study, is any form of CHD resulting from the sudden reduction of blood flow to the heart, which typically leads to the symptoms of shortness of breath and sudden chest pain. This is usually a result of plaque disruption in the coronary arteries due to atherosclerosis. The common risk factors for the disease are smoking, hypertension, diabetes, hyperlipidemia, male sex, physical inactivity, family obesity, and poor nutritional practices. An ACS can lead to a sudden stopping or severe reduction in blood flowing to the heart muscle and when blood cannot flow to the heart muscle, the heart muscle can become damaged and die. A heart attack, also known as a myocardial infarction, is a form of ACS.

Anyone interested in participating in the dal-GenE-2 study should contact their own cardiologist or, alternatively, contact the central study site at:

DalGenE2.clinicaltrial@icm-mhi.org 

You will not be stopping your current medication if you participate in dal-GenE-2. You will continue to take everything prescribed by your doctor.
Informed consent means voluntary choosing to participate in a research study after learning about and understanding the study. The informed consent is an ongoing process. It starts with your first contact with the study doctor and continues throughout the study. You will be informed when there is new information about the study and given the choice to decide whether you want to continue or stop participating. It is important to make sure you understand the study and that all your questions were answered by the study team.

A process of ongoing communication between the study doctor and research participant to inform them when there is new information about the study and give them the choice to decide whether they want to continue or stop participating in the study.

A document that contains information about the study. It protects your rights as a participant and documents the consent.

Genotyping is the process of determining differences in the genetic make-up (genotype) of a person. This test is important to ensure that you have the correct genotype to participate in the study.

The Roche genotype test used for the dal-GenE-2 study involves a small sample of blood (10mL or two teaspoons) taken in the same way as the other blood tests you will have had for the recent ACS.

Your study doctor will receive the results in 24 to 72 hours and will be able to determine if you have the AA genotype required for the study. You will then be assessed for other criteria to see if you are eligible to continue your participation in the study. This test is developed specifically for the purpose of this clinical study research and no other information is generated from this blood test.

For more information on the study or to find a participating clinical trial centre:

For more information on the study or to find a participating clinical trial centre, please send an email to:

DalGenE2.clinicaltrial@icm-mhi.org 

Please include your name and zip or postal code.

dal-GenE-2 is a clinical study to confirm the effect of dalcetrapib (the study drug) on reducing the risk of having a major cardiovascular event (fatal and non-fatal heart attack) in a population with a specific gene variant (AA genotype at variant rs 1967309 in the ADCY9 gene).

Study sites / locations

dal-GenE-2 will be conducted in 150 sites across North America

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