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

The Effect of Intravenous Cangrelor and Oral Ticagrelor on Platelets, the Microcirculation and Myocardial Damage in Patients admitted with STEMI Treated by Primary Percutaneous Coronary Intervention A randomized controlled pilot trial - Effect of IV Cangrelor vs PO Ticagrelor on myocardial damage in STEMI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000195-19-GB

Enrollment

100

Registered

2016-02-17

Start date

2016-03-31

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction MedDRA version: 18.1 Level: PT Classification code 10053460 Term: Antiplatelet therapy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Cangrelor Product Name: Kengrexal Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cangrelor CAS Number: 163706-06-7 Concentration unit: µg/µl microgram(s)/microlitre Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Major heart attack occurs as a result of blockage of coronary arteries due to formation of blood clots consisting mainly of sticky blood cells, and as a result can cause extensive damage to the heart muscle and lead to heart failure and death. One of the main treatment goals is to give antiplatelet drugs (drugs that make sticky blood cells less sticky) as soon as possible. The currently used antiplatelet agents include oral Aspirin in addition to oral Ticagrelor. It is known that patients with major heart attack have reduced absorption from the stomach.Low blood pressure and diversion of blood away from the stomach during a major heart attack reduce absorption and therefore, oral antiplatelet agents are poorly absorbed and have little effect at the time of most need. In this study we aim to demonstrate whether the newer fast acting intravenous Cangrelor has a better antiplatelet effect than the currently used oral Ticagrelor in patients with major heart attacks (STEMI) prior to primar;Secondary Objective: None.;Primary end point(s): We will assess the two drug therapies (Oral Ticagrelor and intravenous Cangrelor) by looking at •The effect of the drugs on blood platelet “stickiness” using VerifyNow and VASP assays from blood samples taken at the time of first coronary balloon inflation, 4 hours post drug loading and 24-36 hours post drug loading. •The effect on the patency of the treated coronary artery as measured by TIMI Flow Grade done immediately post PPCI. •The effect on the flow in the capillary blood vessels in the heart muscle (Index of Microcirculatory Resistance, IMR) using an intracoronary pressure wire performed after treating the culprit vessel. •ECG recording to assess for degree of ST-segment resolution 90 minutes post PPCI. •The effect on the initial degree of heart muscle damage (via a routine blood test to assess troponin levels undertaken 24-36 hours post PPCI). •The effect on the final degree of heart muscle damage using a Cardi	—

Measure

Time frame

Main Objective: Major heart attack occurs as a result of blockage of coronary arteries due to formation of blood clots consisting mainly of sticky blood cells, and as a result can cause extensive damage to the heart muscle and lead to heart failure and death. One of the main treatment goals is to give antiplatelet drugs (drugs that make sticky blood cells less sticky) as soon as possible. The currently used antiplatelet agents include oral Aspirin in addition to oral Ticagrelor. It is known that patients with major heart attack have reduced absorption from the stomach.Low blood pressure and diversion of blood away from the stomach during a major heart attack reduce absorption and therefore, oral antiplatelet agents are poorly absorbed and have little effect at the time of most need. In this study we aim to demonstrate whether the newer fast acting intravenous Cangrelor has a better antiplatelet effect than the currently used oral Ticagrelor in patients with major heart attacks (STEMI) prior to primar;Secondary Objective: None.;Primary end point(s): We will assess the two drug therapies (Oral Ticagrelor and intravenous Cangrelor) by looking at •The effect of the drugs on blood platelet “stickiness” using VerifyNow and VASP assays from blood samples taken at the time of first coronary balloon inflation, 4 hours post drug loading and 24-36 hours post drug loading. •The effect on the patency of the treated coronary artery as measured by TIMI Flow Grade done immediately post PPCI. •The effect on the flow in the capillary blood vessels in the heart muscle (Index of Microcirculatory Resistance, IMR) using an intracoronary pressure wire performed after treating the culprit vessel. •ECG recording to assess for degree of ST-segment resolution 90 minutes post PPCI. •The effect on the initial degree of heart muscle damage (via a routine blood test to assess troponin levels undertaken 24-36 hours post PPCI). •The effect on the final degree of heart muscle damage using a Cardi

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None	—

Countries

United Kingdom

Contacts

Public ContactLorraine Jacques

The Royal Wolverhampton NHS Trust

lorraine.jacques@nhs.net01902695065

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026