The Effect of Intravenous Cangrelor vs oral Ticagrelor on Heart Muscle Damage in Patients with Major Heart Attack.

Phase 1

• Conditions: Acute myocardial infarction; MedDRA version: 18.1Level: PTClassification code 10053460Term: Antiplatelet therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-000195-19-GB
• Lead Sponsor: The Royal Wolverhampton NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-17
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1)Patients presenting with STEMI eligible for PPCI
2)Able to give verbal assent pre procedure and written consent following the procedure.
3)Age =18 years
4)No contraindication to Cangrelor or Ticagrelor
5)Thienopyridine naïve

If a patient gives verbal assent but is unable to provide a written consent at a later stage due to incapacitation, presumed consent will be continued. The reasons why a patient becomes incapacitated and becomes unable to provide a written consent will be recorded during data collection.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1)Be unable to provide verbal assent and written consent
2)Allergic to Aspirin or any of the P2Y12 antagonists in the trial
3)Have pre-existing cardiogenic shock
4)Previous myocardial infarction
5)Have a concurrent septic or inflammatory disease e.g. rheumatoid arthritis, lupus, and pneumonia.
6)Already taking a P2Y12 inhibitor
7)Known bleeding diathesis
8)Significant active bleeding
9)History of intracranial hemorrhage
10)Patients who are being treated with formal anticoagulation (Vitamin K antagonist, Factor II or Xa inhibitors) or have an indication for anticoagulation during the first four hours of the study period. Example is patients known to have atrial fibrillation, pulmonary embolism or deep vein thrombosis.
11)Known severe renal dysfunction requiring renal replacement therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified