A clinical trial comparing treatment with cangrelor (in combination with usual care) to usual care, in subjects who require percutaneous coronary intervention

Each year, over one million patients undergo diagnostic coronary angiography
and are discovered to have flow-limiting atherosclerotic plaques that may be
amenable to PCI. Complications of PCI, and coronary stenting in particular, are
well characterized and include death, myocardial infarction (MI), and the need
for emergent or urgent repeat revascularization. A number of pre-procedural
treatment strategies using anti-thrombotic therapies have
evolved in an attempt to lower the rate of complications related to performance
of PCI. Clopidogrel has become the accepted thienopyridine for
clinical use in the post-stent setting because of its more favorable side
effect profile. It is clear that usual care for patients undergoing PCI
incorporates clopidogrel therapy based on convincing data revealing improved
clinical outcomes when treatment is
instituted immediately after PCI. However, there is ongoing
debate about the optimal timing of clopidogrel administration, and the
appropriate
loading dose, given some suggestive but incomplete data on the benefits of
pre-treatment
Clopidogrel is a prodrug and must be metabolized by the liver in order to
generate the active metabolite. As a result there is a
considerable delay in achieving platelet inhibition following oral
administration.
Furthermore, the binding of the active metabolite irreversible, and
new platelets must be generated in order to reverse the drug*s effect.
The potential benefits of Cangrelor in comparison to Clopidogrel before, and
during the PCI procedure are the following: Cangrelor works directly after
infusion, because the drug is not metabolized in the liver, the effect is
reversible, and it works in 100% of the patient population.

The primary objective of this study is to demonstrate that the efficacy of
cangrelor (combined with usual care) is superior to that of usual care, in
subjects requiring percutaneous coronary intervention (PCI) as measured by a
composite of all-cause mortality, myocardial infarction (MI), and ischemia
driven revascularisation.

This is a multicentre phase3 , prospective, randomized, double-blind,
placebo-controlled, with parallel groups.

De patients receive a 2 hour infusion Cangrelor 30 µg/kg intravenous (IV) bolus
+ 4 µg/kg/minute IV infusion, or placebo IV bolus and infusion, followed by the
standard treatment with Clopidogrel (600mg directly after PCI/infusion followed
by 1 year Clopidogrel 75 mg/dag

The most common side effects reported to date include:
• hematoma (a collection of blood in the tissues) bruising
• bruising at the infusion puncture site
• stomach discomfort
• back pain
• chest pain
As a medication that affects the function of blood platelets , bleeding can
occur at or into any place in the body including:
• into the urine
• at the site of needle sticks
• in the respiratory system

Bleeding events may be severe and result in other complications that may be
long term, including death.