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OpenTrials
Completed

NCT Number: NCT04138641

Dutch Cangrelor Registry

Cangrelor is a fast and directly acting platelet aggregation inhibitor. It is potentially indicated for several types of patients who are undergoing PCI. A nationwide cangrelor registry has up until now not been performed and with the introduction of cangrelor in the Netherlands its efficacy and safety will be determined.

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Key information

Conditions

STEMI - ST Elevation Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST Segment Elevation MI Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

R.S. Hermanides

Zwolle, Overijssel, 8025AB, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • One of the following criteria:
  • Patients naïve for P2Y12 inhibition undergoing PCI
  • Patients with suboptimal P2Y12 inhibition undergoing PCI (patients who vomited after P2Y12 loading, out of hospital cardiac arrest (OHCA) patients with restoration of spontaneous circulation (ROSC), patients loaded with P2Y12 inhibitors though platelet inhibition still insufficient (<2 hours after oral loading dose)
  • (N)STEMI patients loaded with P2Y12 inhibitors with large thrombus burden (thrombus grade 4 or 5) on initial coronary angiography (CAG) and undergoing primary PCI with expected insufficient P2Y12 inhibition

Exclusion criteria

  • Patients on current/chronic treatment with P2Y12 inhibitors
  • Patients (pre) treated with a GPI
  • Patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:
  • hypersensitivity or allergy to and known contra-indication for aspirin, clopidogrel, ticagrelor or cangrelor
  • history of major clinical bleeding or known coagulopathy
  • active bleeding
  • history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
  • known severe liver dysfunction
  • Patients that received any organ transplant or are on a waiting list for any organ transplant
  • Patients undergoing dialysis
  • Pregnant or lactating female
  • Patients currently participating in another investigational drug or device study

Treatment and study plan

cangrelor

Drug

Cangrelor intravenous

Primary outcomes

  1. NACE

    Time frame: 48 hours

    The primary efficacy and safety endpoint is 48 hours Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5).

Secondary outcomes

  1. NACE 30 days

    Time frame: 30 days

    Net Adverse Clinical Events (NACE), which is a composite endpoint of all-cause death (including cardiac death), recurrent myocardial infarction, target vessel revascularization, stroke, definite or probable stent thrombosis and bleeding (BARC type 2-5).

  2. All individual endpoints in-hospital

    Time frame: In-hospital, mostly up to 72 hours.

    All individual endpoints in-hospital

  3. All individual endpoints at 30-days

    Time frame: 30 days

    All individual endpoints at 30-days

  4. TIMI 3 flow post PCI based on angiographic results

    Time frame: post-PCI, mostly up to 1 hour

    TIMI 3 flow post PCI

Sponsors and collaborators

Lead sponsor

Isala

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 24, 2019
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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