NCT01510171

Brief Summary

The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI with bivalirudin monotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

January 11, 2012

Last Update Submit

September 24, 2014

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

platelet inhibitorST-segment elevation myocardial infarctionstentprasugrelticagrelor

Outcome Measures

Primary Outcomes (1)

  • Residual platelet reactivity by VerifyNow

    Residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit.

    2 hours

Secondary Outcomes (1)

  • High residual platelet reactivity

    2,4,8,12 hours

Study Arms (2)

Prasugrel loading dose

ACTIVE COMPARATOR
Drug: Prasugrel

Ticagrelor Loading dose

ACTIVE COMPARATOR
Drug: Ticagrelor

Interventions

PrasugrelDRUG

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 60 mg Prasugrel loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.

Prasugrel loading dose
TicagrelorDRUG

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 180 Ticagrelor loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.

Ticagrelor Loading dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting within 12 hours from the onset of symptoms with STEMI
  • Informed, written consent

You may not qualify if:

  • Age \< 18 years
  • Active bleeding; bleeding diathesis; coagulopathy
  • History of gastrointestinal or genitourinary bleeding \<2 months
  • Major surgery in the last 6 weeks
  • History of intracranial bleeding or structural abnormalities
  • Suspected aortic dissection
  • Any previous TIA/stroke
  • Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux, GPI.
  • Known relevant hematological deviations: Hb \<10 g/dl, Platelet count \<100x10\^9/l
  • Use of coumadin derivatives within the last 7 days
  • Chronic therapy with prasugrel or ticagrelor
  • Known malignancies or other comorbid conditions with life expectancy \<1 year
  • Known severe liver disease, severe renal failure
  • Known allergy to the study medications
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Careggi Hospital

Florence, 50134, Italy

Location

Related Publications (1)

  • Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22.

    PMID: 23500251DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Prasugrel HydrochlorideTicagrelor

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • David Antoniucci, MD

    Careggi Hospital, Division of Invasive Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Division of Invasive Cardiology

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 13, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

January 1, 2013

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

IT(1)