NCT00251576

Brief Summary

A-Phase: Evaluating patients with chest pain who are receiving approved drugs, to estimate the effectiveness of one type of blood thinner as compared to another type of blood thinner. Z-Phase: To evaluate early treatment of patients with long term chest pain (using an approved drug for 30 days, followed by an increased dose of the drug) as compared to patients (treated with diet and 4 months placebo followed by diet and approved drug) in patients who have experienced acute chest pain or heart attack.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,497

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 1999

Typical duration for phase_3

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

November 1, 1999

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

4.4 years

First QC Date

November 9, 2005

Last Update Submit

August 12, 2024

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Z-Phase: combined frequency of the following clinical endpoint events: cardiovascular death, MI, readmission for ACS.

Secondary Outcomes (1)

  • Z-Phase: the incidence of the following endpoints, evaluated individually and as a composite: cardiovascular death, MI, readmission for ACS, coronary revascularization due to documented ischemia and non-hemorrhagic stroke.

Interventions

A-Phase: tirofiban; Z-Phase simvastatinDRUG
Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 yearsDRUG
Comparator: A-Phase: low molecular weight heparin, unfractionated heparinDRUG
Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hoursDRUG
Duration of Treatment: Z-Phase, 2 years.DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A-Phase: Chest pain at rest for 10 minutes, EKG changes or elevated cardiac blood work
  • Z-Phase: elevated cholesterol , plus at least one risk factor ( \> 70 years old, diabetes, history of prior heart or blood vessel disease, chest pain with EKG changes, elevation of cardiac lab work or positive cardiac tests , at least 2 heart vessels blocked \[one \>= 75% and one \>= 50%\])

You may not qualify if:

  • A-Phase: use of some specific cardiac drugs, high risk bleeding, prior blood clotting disorders
  • Z-Phase: elevation in certain cardiac blood tests, no significant heart damage at catheterization, planned cardiac surgery or specific cardiac drugs that lower cholesterol levels, within 6 weeks of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • de Lemos JA, Blazing MA, Wiviott SD, Brady WE, White HD, Fox KA, Palmisano J, Ramsey KE, Bilheimer DW, Lewis EF, Pfeffer M, Califf RM, Braunwald E; Investigators. Enoxaparin versus unfractionated heparin in patients treated with tirofiban, aspirin and an early conservative initial management strategy: results from the A phase of the A-to-Z trial. Eur Heart J. 2004 Oct;25(19):1688-94. doi: 10.1016/j.ehj.2004.06.028.

    PMID: 15451146BACKGROUND

  • de Lemos JA, Blazing MA, Wiviott SD, Lewis EF, Fox KA, White HD, Rouleau JL, Pedersen TR, Gardner LH, Mukherjee R, Ramsey KE, Palmisano J, Bilheimer DW, Pfeffer MA, Califf RM, Braunwald E; Investigators. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA. 2004 Sep 15;292(11):1307-16. doi: 10.1001/jama.292.11.1307. Epub 2004 Aug 30.

    PMID: 15337732BACKGROUND

  • Morrow DA, de Lemos JA, Sabatine MS, Wiviott SD, Blazing MA, Shui A, Rifai N, Califf RM, Braunwald E. Clinical relevance of C-reactive protein during follow-up of patients with acute coronary syndromes in the Aggrastat-to-Zocor Trial. Circulation. 2006 Jul 25;114(4):281-8. doi: 10.1161/CIRCULATIONAHA.106.628909. Epub 2006 Jul 17.

    PMID: 16847150BACKGROUND

  • Wiviott SD, de Lemos JA, Cannon CP, Blazing M, Murphy SA, McCabe CH, Califf R, Braunwald E. A tale of two trials: a comparison of the post-acute coronary syndrome lipid-lowering trials A to Z and PROVE IT-TIMI 22. Circulation. 2006 Mar 21;113(11):1406-14. doi: 10.1161/CIRCULATIONAHA.105.586347. Epub 2006 Mar 13.

    PMID: 16534008BACKGROUND

  • de Lemos JA, Wiviott SD, Murphy SA, Blazing MA, Lewis EF, Califf RM, Pfeffer MA, Braunwald E. Evaluation of the National Cholesterol Education Program Adult Treatment Panel III algorithm for selecting candidates for statin therapy: insights from the A to Z trial. Am J Cardiol. 2006 Sep 15;98(6):739-42. doi: 10.1016/j.amjcard.2006.03.060. Epub 2006 Jul 26.

    PMID: 16950174BACKGROUND

  • Morrow DA, de Lemos JA, Blazing MA, Sabatine MS, Murphy SA, Jarolim P, White HD, Fox KA, Califf RM, Braunwald E; Investigators. Prognostic value of serial B-type natriuretic peptide testing during follow-up of patients with unstable coronary artery disease. JAMA. 2005 Dec 14;294(22):2866-71. doi: 10.1001/jama.294.22.2866.

    PMID: 16352794RESULT

  • Morrow DA, Wiviott SD, White HD, Nicolau JC, Bramucci E, Murphy SA, Bonaca MP, Ruff CT, Scirica BM, McCabe CH, Antman EM, Braunwald E. Effect of the novel thienopyridine prasugrel compared with clopidogrel on spontaneous and procedural myocardial infarction in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction 38: an application of the classification system from the universal definition of myocardial infarction. Circulation. 2009 Jun 2;119(21):2758-64. doi: 10.1161/CIRCULATIONAHA.108.833665. Epub 2009 May 18.

    PMID: 19451347DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Heparin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 10, 2005

Study Start

November 1, 1999

Primary Completion

March 23, 2004

Study Completion

March 23, 2004

Last Updated

August 15, 2024

Record last verified: 2022-02