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P3AMI Antiplatelet Trial

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ClinicalTrials.gov Identifier: NCT02376283
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

Study Description
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Brief Summary:

Major heart attacks are caused by a numerous factors, including sudden clot formation in a coronary artery leading to a blockage and heart muscle death. The clots are largely made of sticky clotting blood cells (platelets). A patient having a major heart attack is treated with emergency primary percutaneous coronary intervention (PPCI) where a wire and balloon are used to reopen the coronary artery and a stent (a slotted metal tube) is placed to keep the artery open.

Aspirin, and one of two other antiplatelet drugs (prasugrel or ticagrelor) are given prior to PPCI to prevent further clots formation. Both antiplatelet drugs are taken in tablet form and in healthy stable patients these drugs take at least 30 min to 2 hours to exert an adequate effect. Often PPCI procedures are performed well within this timescale. It is possible that having a major heart attack limits the bodies ability to absorb the drugs also.

In this study, patients with major or minor heart attacks will be given either prasugrel or ticagrelor as per licensed indications and guideline recommendations. A 15 ml blood sample will be taken at first balloon inflation to reopen the blocked artery, then after 20 minutes, 60 minutes, and 4 hours after taking the drugs. Each blood sample will be subjected to a variety of tests to determine antiplatelet drug activity.

This study will identify which of the two agents used are working effectively during PPCI, given the very short timescales involved. It will also show if patients with major heart attacks absorb the drugs less well than patients with less severe heart attacks. In the future it might be that an intravenous agent will be more valuable in the setting of PPCI.


Condition or disease Intervention/treatment Phase
Heart Attack Drug: Prasugrel Drug: Clopidogrel Drug: ticagrelor Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamics of Platelet P2Y12 Inhibitors in Patients Undergoing Percutaneous Coronary Intervention (PCI) for Acute Myocardial Infarction: A Pilot Study
Actual Study Start Date : March 9, 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
STEMI prasugrel
Patients with diabetes mellitus admitted with STEMI who are under 75 years of age and greater than 60Kg in weight receiving Prasugrel Loading (60mg) and maintenance (10mg per day).
 Drug: Prasugrel
STEMI clopidogrel
Patients admitted with STEMI over the age of 75 or under 60 Kg receiving clopidogrel loading (600 mg) and then maintenance (75mg per day).
 Drug: Clopidogrel
NSTEMI clopidogrel
Patients admitted with NSTEMI/UA over the age of 75 or under 60 Kg receiving clopidogrel loading (600 mg) and then maintenance (75mg per day).
 Drug: Clopidogrel
Patients with NSTEMI
who are under 75 years of age and greater than 60Kg in weight receiving Prasugrel loading (60mg) however: - i. After sample collection patients treated with intracoronary stent placement on the same day as loading will receive prasugrel maintenance dose (10mg per day) as per licensing agreement for prasugrel ii. After sample collection patients who are not stented after loading will receive clopidogrel maintenance dose (75mg per day).
 Drug: Prasugrel
Drug: Clopidogrel
Patients admitted with STEMI receiving ticagrelor loading
Patients admitted with STEMI receiving ticagrelor loading (180 mg) and then maintenance (90mg bd per day)
 Drug: ticagrelor
Patients Admitted with NSTEMI receiving ticagrelor loading
Patients Admitted with NSTEMI receiving ticagrelor loading (180 mg) and then maintenance (90mg bd per day).
 Drug: ticagrelor


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU) [ Time Frame: Balloon Inflation as Baseline, 20, 60, 240 minutes ]
  2. Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml [ Time Frame: Balloon Inflation as Baseline, 20, 60, 240 minutes ]
    The parent compound of Ticagrelor was also analysed within the same patient group of Ticagrelor as it is a directly acting agent that does not require metabolic conversion to its active form.


Secondary Outcome Measures :
  1. Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index) [ Time Frame: Balloon Inflation as Baseline, 20, 60, 240 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients presenting with STEMI for PCI (characterized by chest discomfort, and prominent STsegment elevation)
  2. Patients presenting with NSTEMI (characterized by chest discomfort, raised levels of myocardial enzymes and/or STsegment depression or prominent T wave inversion)
  3. Able to give verbal consent (STEMI patients pre procedure) and/or written consent (STEMI after procedure and NSTEMI patients prior to enrolment).
  4. Age>18 years of age
  5. Able to take Aspirin and either prasugrel or ticagrelor.
  6. Have no concurrent septic or inflammatory illness
  7. Thienopyridine naive

Exclusion Criteria:

  1. Be unable to provide verbal and written consent
  2. Allergic to aspirin or any of the P2Y12 antagonists in the trial
  3. Have preexisting cardiogenic shock
  4. Have a concurrent septic or inflammatory disease e.g. rheumatoid arthritis, lupus, pneumonia.
  5. Already taking a P2Y12 inhibitor
  6. Known bleeding diathesis
  7. Patients under 75 years of age or under 60 kg or those who have had a previous stroke/transient ischaemic attack, will not be eligible for prasugrel but rather ticagrelor.
  8. Patients with a history of intracranial haemorrhage will not receive prasugrel or ticagrelor but rather will receive treatment with clopidogrel.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376283


Locations
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United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
Investigators
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Study Director: James Cotton, MD, FRCP The Royal Wolverhampton NHS Trust
  Study Documents (Full-Text)

Documents provided by The Royal Wolverhampton Hospitals NHS Trust:
Study Protocol and Statistical Analysis Plan  [PDF] May 21, 2015

More Information
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Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02376283     History of Changes
Other Study ID Numbers: 2012-004-04-02-CARD
First Posted: March 3, 2015    Key Record Dates
Results First Posted: September 18, 2019
Last Update Posted: September 18, 2019
Last Verified: August 2019
Keywords provided by The Royal Wolverhampton Hospitals NHS Trust:
STEMI
NSTEMI
PPCI
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Prasugrel Hydrochloride
 Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs